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PT. IDS MEDICAL SYSTEMS INDONESIA

Authorized Representative in Indonesia

Gedung Wisma 76, Lantai 17 & 22, Jl. LetJend. S. Parman Kav.76, Kelurahan Slipi, Kecamatan Palmerah, 11410
419 Products Represented
184 Manufacturers
Total Products
419
Manufacturers
184
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
39 products
9.3%
Kelas Resiko : B
250 products
59.7%
Kelas Resiko : C
116 products
27.7%
Kelas Resiko : D
14 products
3.3%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (419)
Complete portfolio registered with BPOM

PORTEX Polar Preformed Tracheal Tube

Manufacturer:

SMITHS HEALTHCARE MANUFACTURING SA DE CV.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 11, 2025

PORTEX BLUSELECT Suctionaid Tracheostomy Tube

Manufacturer:

SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

PORTEX® Endobronchial Double Lumen

Manufacturer:

SMITHS HEALTHCARE MANUFACTURING SA DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

CADD Cassette Reservoirs-Non Flow Stop

Manufacturer:

SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 5, 2025

CADD 250 ml Medication Cassette Reservoirs

Manufacturer:

SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 5, 2025

PORTEX BLUSELECT Tracheostomy Tube (Uncuffed)

Manufacturer:

SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 3, 2025

PORTEX Nasopharyngeal Airway

Manufacturer:

SMITHS HEALTHCARE MANUFACTURING SA DE C.V.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 3, 2025

MINFOUND PET and Computed Tomography System

Manufacturer:

MINFOUND MEDICAL SYSTEMS CO. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 14, 2025

LAERDAL BaXstrap Spineboard

Manufacturer:

FORMED PLASTICS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 3, 2025

BAXTER Ceiling-Mounted Support System

Manufacturer:

BAXTER MEDICAL SYSTEMS GMBH+ CO. KG.,

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 3, 2025

LAERDAL Stifneck Extrication Collars

Manufacturer:

LAERDAL MEDICAL (SUZHOU) CO. LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 30, 2024

LIFEPAK 20e Defibrillator/Monitor

Manufacturer:

PHYSIO CONTROL INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 23, 2024

LAERDAL Penguin Suction

Manufacturer:

LAERDAL MEDICAL (SUZHOU) CO. LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 20, 2024

STEELCO Endoscope Washer Disinfector

Manufacturer:

STEELCO S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2024

SIUI Apogee 6200 Digital Color Doppler Ultrasound Imaging System

Manufacturer:

SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 12, 2024

STEELCO Drying Cabinet

Manufacturer:

STEELCO S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 12, 2024

CHEST Spiromaster PC-12

Manufacturer:

CHEST MIYAGI FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2024

SIUI Apogee 6300 Digital Color Doppler Ultrasound Imaging System

Manufacturer:

SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2024

SIUI Apogee 1000 Digital Color Doppler Ultrasound Imaging System

Manufacturer:

SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 20, 2024

SIUI Apogee 2300 Digital Color Doppler Ultrasound Imaging System

Manufacturer:

SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 20, 2024

SIUI Apogee 2100 Digital Color Doppler Ultrasound Imaging System

Manufacturer:

SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 14, 2024

LIFEPAK 1000 Defibrillator

Manufacturer:

PHYSIO CONTROL INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 13, 2024

LIFEPAK 15 Monitor/Defibrillator

Manufacturer:

PHYSIO CONTROL INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 13, 2024

LIFEPAK 1000 Defibrillator

Manufacturer:

PHYSIO CONTROL INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 13, 2024

LUCAS 3 Chest Compression System

Manufacturer:

JOLIFE AB

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 11, 2024

HILL-ROM Transport Stretcher

Manufacturer:

HILL-ROM DE MEXICO S DE RL DE CV.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2024

STEELCO Washer Disinfector

Manufacturer:

STEELCO S.P.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 23, 2024

STEELCO Washer Disinfector

Manufacturer:

STEELCO S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 23, 2024

LIFEPAK 15 Monitor/Defibrillator

Manufacturer:

PHYSIO CONTROL INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 23, 2024

STEELCO Low Temperature Sterilizer

Manufacturer:

STEELCO S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 23, 2024

STEELCO Low Temperature Sterilizer

Manufacturer:

STEELCO S.P.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 18, 2024

HAMILTON IntelliCuff

Manufacturer:

HAMILTON MEDICAL AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 18, 2024

STEELCO Washer Disinfector

Manufacturer:

STEELCO S.P.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 18, 2024

STEELCO Low Temperature Sterilizer

Manufacturer:

STEELCO S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 18, 2024

SIUI Apogee 6500 Digital Color Doppler Ultrasound Imaging System

Manufacturer:

SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2024

SIUI Apogee 3500 Digital Color Doppler Ultrasound Imaging System

Manufacturer:

SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 10, 2024

STEELCO Washer Disinfector

Manufacturer:

STEELCO S.P.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 10, 2024

STEELCO Bedpan Washer BP 100 HAE

Manufacturer:

STEELCO S.P.A.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 9, 2024

STEELCO Washer Disinfector

Manufacturer:

STEELCO S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2024

STEELCO Low Temperature Sterilizer

Manufacturer:

STEELCO S.P.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2024

SIUI Apogee 5300 Digital Color Doppler Ultrasound Imaging System

Manufacturer:

SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2024

STEELCO Washer Disinfector

Manufacturer:

STEELCO S.P.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2024

HILL-ROM Accella Therapy

Manufacturer:

HILL-ROM S.A.S

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2024

Hill-Rom® 900

Manufacturer:

HILL-ROM S.A.S

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2024

EXCIPLEX UV Light Therapy Device

Manufacturer:

CLARTEIS SAS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2024

STEELCO Bedpan Washer BP 100 HSE

Manufacturer:

STEELCO S.P.A.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 7, 2024

STEELCO Bedpan Washer

Manufacturer:

STEELCO S.P.A.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 7, 2024

SIUI Apogee 5800 Digital Color Doppler Ultrasound Imaging System

Manufacturer:

SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 1, 2024

SIUI Apogee 3300 Digital Color Doppler Ultrasound Imaging System

Manufacturer:

SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 1, 2024

SUNTECH Tango M2 Blood Pressure Monitor

Manufacturer:

SUNTECH MEDICAL INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 1, 2024

HILL-ROM PROGRESSA Bed System

Manufacturer:

HILL-ROM INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 23, 2024

HILL-ROM Affinity Four Birthing Bed

Manufacturer:

HILL-ROM INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 17, 2024

HILL-ROM Centuris Bed System

Manufacturer:

OPTIMA HEALTHCARE INC (GD)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 17, 2024

HAMILTON C6

Manufacturer:

HAMILTON MEDICAL AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 12, 2024

HILL-ROM Progressa+ Bed

Manufacturer:

HILL-ROM INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 7, 2024

SLE 1500 Gas Blender

Manufacturer:

SLE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 5, 2024

SILHOUET-TONE MPR Toroïdal RF

Manufacturer:

SILHOUET-TONE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 3, 2024

INNOQ Humidifier Chamber

Manufacturer:

EXCELLENTCARE MEDICAL (HUIZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 3, 2024

PRUNUS Anesthesia Machine

Manufacturer:

SHENZHEN PRUNUS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 7, 2024

PRUNUS Anesthesia Machine

Manufacturer:

SHENZHEN PRUNUS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 7, 2024

PRUNUS Anesthesia Machine

Manufacturer:

SHENZHEN PRUNUS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 7, 2024

PRUNUS Anesthesia Machine

Manufacturer:

SHENZHEN PRUNUS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 7, 2024

PRUNUS Anesthesia Machine

Manufacturer:

SHENZHEN PRUNUS MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2024

INNOQ Disposable Patient Monitor Pre-Wired

Manufacturer:

MEDICO ELECTRODES INTERNATIONAL LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

SLE6000 Infant Ventilator

Manufacturer:

SLE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2024

INNOQ Ventilator Breathing Circuit

Manufacturer:

EXCELLENTCARE MEDICAL (HUIZHOU) LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 25, 2024

SLE Medical Air Compressor

Manufacturer:

EKOM SPOL S.R.O.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 24, 2024

BAXTER Operating Table

Manufacturer:

BAXTER MEDICAL SYSTEMS GMBH + CO. KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 22, 2024

INNOQ Surgical Pack

Manufacturer:

COBES HEALTHCARE (HEFEI) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2024

SLE Medical Air Compressor

Manufacturer:

EKOM SPOL S.R.O.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2024

SLE6000 Infant Ventilator

Manufacturer:

SLE LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 10, 2024

INNOQ Anesthesia Breathing Circuit

Manufacturer:

EXCELLENTCARE MEDICAL (HUIZHOU) LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 8, 2024

BAXTER PST 500 Mobile Operating Table

Manufacturer:

BAXTER MEDICAL SYSTEMS GMBH + CO. KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2024

SLE6000 Infant Ventilator

Manufacturer:

SLE., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 2, 2024

SLE Infant Ventilator

Manufacturer:

SLE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 2, 2024

BAXTER TruVidia HD (Camera module and Control Unit)

Manufacturer:

BAXTER MEDICAL SYSTEMS GMBH + CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 24, 2024

NATROX Oxygen Generator Kit (OG)

Manufacturer:

INOTEC AMD LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 24, 2024

BAXTER Ceiling-Mounted Support System

Manufacturer:

BAXTER MEDICAL SYSTEMS GMBH + CO., KG

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 13, 2024

BAXTER Ceiling-Mounted Support System

Manufacturer:

BAXTER MEDICAL SYSTEMS GMBH + CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 13, 2024

VYGON Nutrisafe 2 Polyurethane Feeding Tube

Manufacturer:

VYGON COLOMBIA S.A,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2024

CHRISTIE VeinViewer 3.0 Flex

Manufacturer:

MINNETRONIX INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 9, 2024

CHRISTIE VeinViewer 4.0 Vision2

Manufacturer:

MINNETRONIX INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 9, 2024

HAMILTON T1

Manufacturer:

HAMILTON MEDICAL AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 4, 2024

HAMILTON C1

Manufacturer:

HAMILTON MEDICAL AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 4, 2024

HAMILTON MR1

Manufacturer:

HAMILTON MEDICAL AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 3, 2024

EOS ECMO Adult Ph.I.S.I.O OXY Module

Manufacturer:

SORIN GROUP ITALIA S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 21, 2024

INNOQ Disposable Solid Gel Electrodes

Manufacturer:

MEDICO ELECTRODES INTERNATIONAL LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 21, 2024

INNOQ Disposable Liquid Gel Electrodes

Manufacturer:

MEDICO ELECTRODES INTERNATIONAL LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 21, 2024

VYGON Nutrisafe2 Polyurethane Feeding Tube (without stylet)

Manufacturer:

VYGON PORTUGAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2024

InnoQ Hemodialysis Catheter Kit II (Curved) Double Lumen

Manufacturer:

SCW MEDICATH LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 7, 2024

InnoQ Hemodialysis Catheter Kit II (Curved) Triple Lumen

Manufacturer:

SCW MEDICATH LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 7, 2024

INNOQ Hemodialysis Catheter Kit I (Pre-Curved) Double Lumen

Manufacturer:

SCW MEDICATH LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 7, 2024

InnoQ Hemodialysis Catheter Kit II (Pre-curved) Double Lumen

Manufacturer:

SCW MEDICATH LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 7, 2024

MediLUX (Medical Photodynamic Therapy System)

Manufacturer:

SHANDONG HUAMEI TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 7, 2024

InnoQ Hemodialysis Catheter Kit I (Curved) Triple Lumen

Manufacturer:

SCW MEDICATH LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 7, 2024

HB Plus PROJECTION

Manufacturer:

PHARMARESEARCH CO., LTD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 6, 2024

InnoQ Hemodialysis Catheter Kit I (Straight) Double Lumen

Manufacturer:

SCW MEDICATH LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 30, 2024

INNOQ Hemodialysis Catheter Kit I (Curved) Double Lumen

Manufacturer:

SCW MEDICATH LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 30, 2024

MOSTCAREUP Haemodynamic Monitor - Endless

Manufacturer:

PROJECT ENGINEERING S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 23, 2024

Infusion Line with Lipid Filter

Manufacturer:

SIPA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 17, 2024

VAPOTHERM High Velocity Therapy System HVT 2.0

Manufacturer:

BAJA FUR S.A. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 11, 2024

NATUS MADSEN AccuScreen

Manufacturer:

NATUS MANUFACTURING LIMITED.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2024

VYGON Polyurethane Umbilical Catheter

Manufacturer:

VYGON PORTUGAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 28, 2024

PORTEX BLUSELECT Tracheostomy Tube

Manufacturer:

SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 29, 2024

AFENTUBE Aspiration Tubing

Manufacturer:

WEIHAI HEMO JIRUI BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 27, 2024

NATUS Madsen Alpha

Manufacturer:

NATUS MANUFACTURING LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2024

VYGON Boussignac Candle

Manufacturer:

SIPA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 22, 2024

PICOSURE Pro

Manufacturer:

CYNOSURE, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 17, 2024

TracLine Intermediate Catheter

Manufacturer:

WEIHAI HEMO JIRUI BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 16, 2024

PICOSURE

Manufacturer:

CYNOSURE, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 15, 2024

RevLite SI Laser System

Manufacturer:

CYNOSURE, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 15, 2024

INNOQ ResAid Disposable Laryngeal Mask Airway (Silicone)

Manufacturer:

WELL LEAD MEDICAL CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 14, 2024

AFENTTA Aspiration Catheter

Manufacturer:

WEIHAI HEMO JIRUI BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 11, 2024

NATUS NeoBLUE 3 LED Phototherapy

Manufacturer:

CREATION TECHNOLOGIES LP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 3, 2024

ESSENZ Heart Lung Machine

Manufacturer:

LIVANOVA DEUTSCHLAND GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 3, 2024

NATUS CFM Olympic Brainz Monitor

Manufacturer:

NATUS NEUROLOGY INCORPORATED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 3, 2024

VYGON Echoplex+

Manufacturer:

SIPA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 3, 2024

NATUS neoBLUE Blanket LED Phototherapy System

Manufacturer:

KATECHO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 28, 2023

Leadercath Set (Arterial + pack 8 cm Tegaderm)

Manufacturer:

SAP

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2023

NATUS Echo-Screen III

Manufacturer:

CREATION TECHNOLOGIES LP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 20, 2023

NATUS Echo-Screen III

Manufacturer:

CREATION TECHNOLOGIES LP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 18, 2023

NATUS neoBLUE Compact LED Phototerapy

Manufacturer:

CREATION TECHNOLOGIES LP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 18, 2023

NATUS Echo-Screen III

Manufacturer:

CREATION TECHNOLOGIES LP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 15, 2023

VASERLipo System

Manufacturer:

SOLTA MEDICAL, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2023

Multicath4expert UP

Manufacturer:

VYGON GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2023

Multicath3expert UP

Manufacturer:

VYGON GMBH & CO. KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2023

NATUS ALGO 3i Newborn Hearing Screener

Manufacturer:

CREATION TECHNOLOGIES LP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 15, 2023

Multicath2expert Up

Manufacturer:

VYGON GMBH & CO. KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 14, 2023

INNOQ Surgical Drape and Pack

Manufacturer:

MEDPRO HEALTHCARE CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2023

Precision Flow Plus Unit

Manufacturer:

VAPOTHERM, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2023

Maxfloexpert

Manufacturer:

VYGON GMBH & CO. KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 4, 2023

TrachFlush

Manufacturer:

AW TECHNOLOGIES APS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 4, 2023

BIOPTIMAL Biotray Procedure Pack

Manufacturer:

BIOXIN MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 30, 2023

VYGON Umbilical Catheter

Manufacturer:

VYGON PORTUGAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 28, 2023

SONOQUEEN Focused Ultrasound Stimulator System

Manufacturer:

NEWPONG CO., LTD., SEOUL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 27, 2023

KCI ActiV.A.C Therapy Unit

Manufacturer:

KCI MANUFACTURING.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2023

KCI V.A.C ULTA Therapy Unit

Manufacturer:

KCI MANUFACTURING.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2023

INNOQ Heat-Sealing Flat Reel

Manufacturer:

SHANGHAI JIANZHONG MEDICAL PACKAGING CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2023

truSculpt iD Medical System

Manufacturer:

JOHARI DIGITAL HEALTHCARE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 8, 2023

V.A.C GRANUFOAM Dressing

Manufacturer:

KCI MANUFACTURING

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2023

Multistar 3 UP

Manufacturer:

VYGON GMBH & CO. KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 8, 2023

V.A.C. WHITEFOAM ™ Dressing featuring SENSAT. R.A.C ™ Technology

Manufacturer:

KCI POLYMEDICS BV

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 8, 2023

INNOQ Heat-Sealing Gusseted Reel

Manufacturer:

SHANGHAI JIANZHONG MEDICAL PACKAGING CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2023

BIOPTIMAL Central Venous Catheter & Central Venous Catheter Kit (Single Lumen)

Manufacturer:

BIOXIN MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 3, 2023

Heater Cooler System STÖCKERT 3T

Manufacturer:

LIVANOVA DEUTSCHLAND GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2023

BIOPTIMAL Central Venous Catheter & Central Venous Catheter Kit (Quad Lumen)

Manufacturer:

BIOXIN MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 3, 2023

BIOPTIMAL Central Venous Catheter & Central Venous Catheter Kit (Triple Lumen)

Manufacturer:

BIOXIN MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 3, 2023

DIDECO Perfusion Tubing Systems

Manufacturer:

SORIN GROUP ITALIA S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2023

XTRA ™ Procedure Set

Manufacturer:

SORIN GROUP ITALIA S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 2, 2023

V.A.C WhiteFoam Dressing

Manufacturer:

KCI POLYMEDICS BV

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 1, 2023

V.A.C VERAFLO ™ Dressing System

Manufacturer:

VENUSA DE MEXICO S. DE R.L DE C.V. (A LAKE REGION MEDICAL COMPANY)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 30, 2023

ABTHERA ™ SENSAT. R.A.C ™ Open Abdomen Dressing

Manufacturer:

AVAILMED S.A DE C.V

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 30, 2023

JW Pharmaceutical Infant Incubator

Manufacturer:

JW PHARMACEUTICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 30, 2023

V.A.C GRANUFOAM ™ Dressing

Manufacturer:

AVAILMED S.A.DE C.V

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 30, 2023

V.A.C GRANUFOAM SILVER™ DRESSING

Manufacturer:

KCI MANUFACTURING

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 29, 2023

BIOPTIMAL Central Venous Catheter & Central Venous Catheter Kit (Triple Lumen)

Manufacturer:

BIOXIN MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 27, 2023

XTRA Autotransfusion cell Separator 230 V

Manufacturer:

LIVANOVA DEUTSCHLAND GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2023

BIOPTIMAL Central Venous Catheter & Central Venous Catheter Kit (Double Lumen)

Manufacturer:

BIOXIN MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 27, 2023

STÖCKERT S5 Heart-Lung Machine System

Manufacturer:

LIVANOVA DEUTSCHLAND GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2023

BIOPTIMAL Central Venous Catheter & Central Venous Catheter Kit (Single Lumen)

Manufacturer:

BIOXIN MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2023

Bioptimal Central Venous Catheter & Central Venous Catheter Kit (Double Lumen)

Manufacturer:

BIOXIN MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2023

REVOLUTION 5 Centrifugal Pump

Manufacturer:

SORIN GROUP ITALIA S.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 25, 2023

DIDECO KIDS, Infant -Newborn Oxygenators

Manufacturer:

SORIN GROUP ITALIA S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 19, 2023

DIDECO KIDS, Infant - Newborn Oxygenators

Manufacturer:

SORIN GROUP ITALIA S.R.L. (MIRANDOLA)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 19, 2023

INSPIRE ™, Adult and Small Adult Oxygenators

Manufacturer:

SORIN GROUP ITALIA S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 19, 2023

DIDECO EOS ECMO M PHISIO

Manufacturer:

SORIN GROUP ITALIA S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 16, 2023

INNOQ Image Intensifier Cover

Manufacturer:

COBES HEALTH CARE (HEFEI) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 10, 2023

Silverstim

Manufacturer:

SIPA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 4, 2023

NEUROLIGHT Portable Pupillometer

Manufacturer:

IDMED, MARSEILLE

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 7, 2023

CHEST Pulmonary Function Test System

Manufacturer:

CHEST MIYAGI FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 3, 2023

CHEST Spirometry System

Manufacturer:

CHEST MIYAGI FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 3, 2023

TOFSCAN Neuromuscular Transmission Monitor

Manufacturer:

IDMED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 3, 2023

ALGISCAN Pupillary Algesimeter

Manufacturer:

IDMED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 3, 2023

INNOQ Anesthesia Mask

Manufacturer:

ZHEJIANG HAISHENG MEDICAL DEVICE CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 2, 2023

CHEST HI-301 Spirometry System

Manufacturer:

CHEST MIYAGI FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2023

CHEST Respiratory Diagnostic

Manufacturer:

CHEST MIYAGI FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 31, 2023

CHESTMATE Handheld Spirometer

Manufacturer:

CHEST MIYAGI FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2023

M-TECHNOLOGY Automatic Endoscope Washer & Disinfector

Manufacturer:

M-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2023

CHEST Spirometry System

Manufacturer:

CHEST MIYAGI FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2023

CHEST Spirometry System w/Spirobank

Manufacturer:

CHEST MIYAGI FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2023

CHEST Airway Hyper-Reactivity Test System

Manufacturer:

CHEST MIYAGI FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 17, 2023

M-TECHNOLOGY Suction Unit

Manufacturer:

M-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 15, 2023

M-TECHNOLOGY Portable Suction Unit

Manufacturer:

M-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 7, 2023

NONIN Table Top / Portable Digital Pulse Oximeter

Manufacturer:

NONIN MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 3, 2023

NONIN PalmSat® Hand Held Pulse Oximeter

Manufacturer:

NONIN MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 1, 2023

NONIN AVANT Tabletop/Portable Pulse Oximeter

Manufacturer:

NONIN MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 1, 2023

NONIN Digital Handheld Pulse Oximeter

Manufacturer:

NONIN MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 31, 2023

NONIN PALMSAT Digital Handheld Pulse Oximeter

Manufacturer:

NONIN MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 31, 2023

NONIN Finger Pulse Oximeter

Manufacturer:

NONIN MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 31, 2023

NONIN Finger Pulse Oximeter

Manufacturer:

NONIN MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 31, 2023

NONIN SenSmart Model X-100 Universal Oximetry System

Manufacturer:

NONIN MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 28, 2023

NONIN AVANT Non Invasive Blood Pressure Monitor and Digital Pulse Oximeter

Manufacturer:

NONIN MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 28, 2023

NONIN Table Top / Portable Pulse Oximeter

Manufacturer:

NONIN MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 25, 2023

BAXTER TruSystem 3000 Surgical Table Universal

Manufacturer:

BAXTER MEDICAL SYSTEMS (SUZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 18, 2023

SECA Medical Body Composition Analyzer 554

Manufacturer:

SECA GMBH & CO. Medical history

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 17, 2023

LOCOPLEX Regional Analgesia Needle

Manufacturer:

SIPA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2023

BAXTER TruSystem Operating Table

Manufacturer:

BAXTER MEDICAL SYSTEMS GMBH + CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 30, 2023

BAXTER TruLight 5000/3000 Surgical Light

Manufacturer:

Baxter Medical Systems GmbH + Co.KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2023

BAXTER iLED 7 Surgical Light

Manufacturer:

Baxter Medical Systems GmbH + Co.KG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 19, 2023

TARGETCOOL

Manufacturer:

RECENSMEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 6, 2023

DIGISTAT Care

Manufacturer:

ASCOM UMS SRL UNIPERSONALE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 29, 2023

BAXTER TruVidia Wireless Camera

Manufacturer:

BAXTER MEDICAL SYSTEMS GMBH + CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 24, 2023

JW PHARMACEUTICAL Gynecological Examining Table

Manufacturer:

JW PHARMACEUTICAL Corporation.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2023

ATOM Infant Incubator (w/O2 Controller Unit)

Manufacturer:

ATOM MEDICAL CORPORATION URAWA FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2023

ATOM AIR INCU I Infant Incubator

Manufacturer:

ATOM MEDICAL CORPORATION URAWA FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2023

ATOM Infant Warmer Model 103

Manufacturer:

ATOM MEDICAL CORPORATION URAWA FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2023

ATOM Infant Incubator Model 100 Dual Incu i (w/ O2 Controller Unit)

Manufacturer:

ATOM MEDICAL CORPORATION URAWA FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 15, 2023

ATOM RESUSCI FLOW Resuscitation Unit

Manufacturer:

ATOM MEDICAL CORPORATION URAWA FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 15, 2023

ATOM Phototherapy Unit

Manufacturer:

ATOM MEDICAL CORPORATION URAWA FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 15, 2023

ATOM Sunflower Warmer

Manufacturer:

ATOM MEDICAL CORPORATION URAWA FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 15, 2023

ATOM Infant Incubator

Manufacturer:

ATOM MEDICAL CORPORATION URAWA FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 15, 2023

JW PHARMACEUTICAL Operating Table

Manufacturer:

JW PHARMACEUTICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 4, 2023

JW PHARMACEUTICAL Operating Light

Manufacturer:

JW PHARMACEUTICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 28, 2023

JW PHARMACEUTICAL Operating Light

Manufacturer:

JW PHARMACEUTICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 27, 2023

ATOM Infant Incubator Model 101 Incu i (w/o O2 Controller Unit)

Manufacturer:

ATOM MEDICAL CORPORATION URAWA FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 27, 2023

JW PHARMACEUTICAL Operating Light

Manufacturer:

JW PHARMACEUTICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 27, 2023

JW PHARMACEUTICAL Operating Table

Manufacturer:

JW PHARMACEUTICAL CORPORATION.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 27, 2023

JW PHARMACEUTICAL Infant Warmer

Manufacturer:

JW PHARMACEUTICAL CORPORATION.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

SLE Adaptive Nasal CPAP Therapy System

Manufacturer:

SLE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 19, 2023

OCTOPUS 3

Manufacturer:

SIPA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 19, 2023

JW PHARMACEUTICAL Operating Light

Manufacturer:

JW PHARMACEUTICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 18, 2023

ATOM Resuscitation Unit

Manufacturer:

ATOM MEDICAL CORPORATION URAWA FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 18, 2023

VYGON Qimo

Manufacturer:

SIPV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 10, 2023

JW PHARMACEUTICAL Pediatric Phototherapy Unit

Manufacturer:

JW PHARMACEUTICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 10, 2023

JW PHARMACEUTICAL Gynecological Examining Table

Manufacturer:

JW PHARMACEUTICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 6, 2023

ATOM Resuscitation Unit 104 E Type

Manufacturer:

ATOM MEDICAL CORPORATION URAWA FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 5, 2023

OCTOPUS 2

Manufacturer:

SIPA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 4, 2023

Infant Incubator

Manufacturer:

JW PHARMACEUTICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 28, 2023

JW PHARMACEUTICAL Operating Light

Manufacturer:

JW PHARMACEUTICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 27, 2023

SLE Miniflow nCPAP Generator and Accessories

Manufacturer:

MEDIN MEDICAL INNOVATIONS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 15, 2023

ENLIGHTEN SR Medical Laser System

Manufacturer:

CUTERA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 13, 2023

HAMILTON-C3 Intelligent Ventilation

Manufacturer:

HAMILTON MEDICAL AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 27, 2023

LIFEPAK 20e Defibrillator/Monitor

Manufacturer:

PHYSIO CONTROL INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 22, 2023

LIFEPAK 20e Defibrillator/Monitor

Manufacturer:

PHYSIO CONTROL INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 22, 2023

INNOQ Disposable Patient Monitor Electrode

Manufacturer:

SHANGHAI INTCO ELECTRODE MANUFACTURING CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2023

LAERDAL Pocket Mask

Manufacturer:

LAERDAL MEDICAL AS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2022

VYGON Locoplex Regional Analgesia Needle

Manufacturer:

VYGON

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2022

NUTRISAFE2 A-VY Syringe For Safety Enteral Connection

Manufacturer:

ARTSANA SPA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2022

VYGON Neohelp

Manufacturer:

VYGON.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 25, 2022

VYGON Umbilical Catheter

Manufacturer:

VYGON

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 23, 2022

MOSTCAREUP Haemodynamic Monitor- Endless

Manufacturer:

PROJECT ENGINEERING S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2022

CADD-Solis 2110 Ambulatory Infusion Pump

Manufacturer:

SMITHS MEDICAL ASD INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2022

MOSTCAREUP Haemodynamic Monitor - On Demand

Manufacturer:

PROJECT ENGINEERING S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2022

VYGON Nutrisafe2 Extension Tube

Manufacturer:

DIMEQUIP

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2022

VYGON Silverstim

Manufacturer:

VYGON

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 15, 2022

VYGON Polyurethane Umbilical Catheter

Manufacturer:

VYGON

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 14, 2022

PLEXYGON Nerve Stimulator

Manufacturer:

VYGON ITALIA SRL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 13, 2022

DermLite DL200 Hybrid

Manufacturer:

DERMLITE LLC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 12, 2022

LAERDAL V-VAC

Manufacturer:

LAERDAL MEDICAL (SUZHOU) CO. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 12, 2022

DermLite DL1

Manufacturer:

DERMLITE LLC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 12, 2022

VYGON Boussignac Candle

Manufacturer:

VYGON S.A.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 11, 2022

DERMLITE DL4 with PigmentBoost Plus

Manufacturer:

DERMLITE, LLC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 9, 2022

DermLite Lumio 2

Manufacturer:

DermLite, LLC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 9, 2022

VYGON Double Lumen Polyurethane Umbilical Catheter

Manufacturer:

SIPV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 8, 2022

PREMICATH

Manufacturer:

VYGON GMBH & CO. K.G

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 8, 2022

VYGON Echoplex+

Manufacturer:

VYGON.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2022

OCTOPUS 2

Manufacturer:

VYGON

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 7, 2022

VYGON Bionector

Manufacturer:

SIPV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 7, 2022

LIFECATH PICC Pur

Manufacturer:

VYGON GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 7, 2022

LEADERCATH Set – Arterial + Pack 8cm TEGADERM

Manufacturer:

VYGON

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 7, 2022

VYGON Infusion Line with Lipid Filter

Manufacturer:

VYGON

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 7, 2022

OCTOPUS 3

Manufacturer:

VYGON

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 7, 2022

LEADERFLEX

Manufacturer:

VYGON GMBH & CO. K.G

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 7, 2022

RTM3

Manufacturer:

MEDICAL TECHNOLOGY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 6, 2022

VYGON Emergency APO CPAP Kit

Manufacturer:

VYGON S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2022

MULTICATH 2

Manufacturer:

VYGON GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 5, 2022

NUTRILINE

Manufacturer:

VYGON GMBH & CO. KG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 5, 2022

VYGON Nutrisafe2 Feeding Tube

Manufacturer:

DIMEQUIP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2022

LEADERCATH Arterial

Manufacturer:

SIPV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 5, 2022

VYGON Double Tube Nasal Ventilation

Manufacturer:

SIPV.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 30, 2022

NUTRILINE TWINFLO

Manufacturer:

VYGON GMBH & CO. Medical history

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 28, 2022

INNOQ Ultrasound Probe Cover

Manufacturer:

NULATEX SDN. BHD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2022

HAMILTON - C6

Manufacturer:

HAMILTON MEDICAL AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 20, 2022

CANON Digital Radiography CXDI 701C Wireless System

Manufacturer:

CANON COMPONENTS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2022

CANON Digital Radiography CXDI 710C Wireless System

Manufacturer:

CANON COMPONENTS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 3, 2022

INNOQ Surgical Gown

Manufacturer:

COBES HEALTHCARE (HEFEI) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 3, 2022

INNOQ Bacterial/Viral Filter

Manufacturer:

EXCELLENTCARE MEDICAL (HUIZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 7, 2022

HILL-ROM THE VEST Airway Clearance System

Manufacturer:

FLEXTRONICS MANUFACTURING (SINGAPORE) PTE., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 29, 2022

InnoQ Reusable SpO2 Sensor and Cable

Manufacturer:

SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 25, 2022

INNOQ Single Patient SpO2 Sensor and Cable

Manufacturer:

SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

BIOPTIMAL Biotray Procedure Pack

Manufacturer:

JW ICU MEDICAL LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

BIOPTIMAL Biotrans Pressure Monitoring Kit

Manufacturer:

JW ICU MEDICAL LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 16, 2022

NORSELD Copper Bromide Laser

Manufacturer:

NORSELD PTY., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 9, 2022

BIOPTIMAL Embolectomy Catheter

Manufacturer:

JW ICU MEDICAL LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 5, 2022

HAMILTON H900 Intelligent Humidification

Manufacturer:

HAMILTON MEDICAL AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 5, 2022

HAMILTON - IntelliCuff Pressure Controller

Manufacturer:

HAMILTON MEDICAL AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 4, 2022

TRUMPF MARS 2.02 Operating Table

Manufacturer:

TRUMPF MEDIZIN SYSTEME GMBH + CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 15, 2022

TRUMPF TruSystem 3000 Operating Table

Manufacturer:

TRUMPF MEDICAL SYSTEMS (TAICANG) CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2022

ARROWg+ard Blue Central Venous Catheter (CVC) Two Lumen

Manufacturer:

ARROW INTERNATIONAL C.R. A.S

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 10, 2022

STEELCO Washer Disinfector

Manufacturer:

STEELCO S.P.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 6, 2022

TRUMPF Surgical Light

Manufacturer:

TRUMPF MEDIZIN SYSTEME GMBH + CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2022

TRUMPF Surgical Light

Manufacturer:

TRUMPF MEDIZIN SYSTEME GMBH + CO. Medical history

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 23, 2022

TRUMPF Surgical Light

Manufacturer:

TRUMPF MEDIZIN SYSTEME GMBH + CO. Medical history.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2022

TRUMPF Surgical Light

Manufacturer:

TRUMPF MEDIZIN SYSTEME GMBH + CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 19, 2022

INNOQ Ultrasound Gel

Manufacturer:

ISD MEDITECH SDN BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 19, 2022

ARROW Three Lumen Central Venous Catheter (CVC)

Manufacturer:

ARROW INTERNATIONAL C.R. A.S

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 17, 2022

CLEAR + BRILLIANT Laser System

Manufacturer:

SANMINA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 13, 2022

ARROWg+ard Blue Three Lumen Central Venous Catheter (CVC)

Manufacturer:

ARROW INTERNATIONAL C.R. A.S

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 13, 2022

INNOQ Transparent Dressing Plus Pad

Manufacturer:

JIANGSU NEWVALUE MEDICAL PRODUCTS CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 10, 2022

THERMAGE FLX System and Accessories

Manufacturer:

SOLTA MEDICAL, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 9, 2022

INNOQ Disposable Bacterial/Viral Filter

Manufacturer:

ZHEJIANG HAISHENG MEDICAL DEVICE CO.LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 9, 2022

THERMAGE CPT System and Accessories

Manufacturer:

SOLTA MEDICAL, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 28, 2022

INNOQ Disposable Anesthesia Breathing Circuit

Manufacturer:

ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 27, 2022

INNOQ Transparent Dressing

Manufacturer:

JIANGSU NEWVALUE MEDICAL PRODUCTS CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 21, 2022

INNOQ Anesthesia Mask

Manufacturer:

ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 15, 2022

TRUMPF Surgical Light

Manufacturer:

TRUMPF MEDIZIN SYSTEME GMBH + CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 11, 2022

TRUMPF Surgical Light

Manufacturer:

TRUMPF MEDIZIN SYSTEME GMBH + CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 11, 2022

FUKUDA DENSHI Advanced Electrocardiograph

Manufacturer:

FUKUDA DENSHI CO., LTD SHIROI FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 10, 2022

TRUMPF Surgical Light

Manufacturer:

TRUMPF MEDIZIN SYSTEME GMBH + CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 9, 2022

TRUMPF Surgical Light

Manufacturer:

TRUMPF MEDIZIN SYSTEME GMBH + CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 8, 2022

TRUMPF Surgical Light

Manufacturer:

TRUMPF MEDIZIN SYSTEME GMBH + CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 8, 2022

PST 300 Mobile Operating Table

Manufacturer:

TRUMPF MEDICAL SYSTEMS (TAICANG) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2022

INNOQ CTG Paper

Manufacturer:

TELE-PAPER (M) SDN., BHD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 14, 2022

INNOQ Ultrasound Paper

Manufacturer:

TELE-PAPER (M) SDN., BHD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 14, 2022

KCI InfoV.A.C Therapy Unit

Manufacturer:

KCI MANUFACTURING.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2022

InnoQ ECG Paper

Manufacturer:

TELE-PAPER (M) SDN., BHD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 27, 2022

RESPOKARE Child Face Mask

Manufacturer:

INNONIX TECHNOLOGIES (SHENZHEN) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 25, 2022

XEO Medical Laser System

Manufacturer:

CUTERA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 3, 2022

VAPOTHERM High Velocity Therapy System HVT 2.0

Manufacturer:

VAPOTHERM, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 28, 2021

EXCEL V+ Medical Laser System

Manufacturer:

CUTERA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 1, 2021

HAUX-STARCOM Hyperbaric Medical Chamber Systems

Manufacturer:

HAUX-LIFE SUPPORT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 30, 2021

EXCEL V Medical Laser System

Manufacturer:

CUTERA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 16, 2021

BBLOVE Infrared Thermometer

Manufacturer:

ALICN MEDICAL (SHENZHEN) INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2021

ARROW-CLARK™ VECTORFLOW™ Retrograde Hemodialysis Catheterization Set

Manufacturer:

ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 8, 2021

Rejumate Injector

Manufacturer:

PHARMARESEARCH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2021

LMA Unique

Manufacturer:

THE LARYNGEAL MASK COMPANY (M) SDN., BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2021

REJURAN®

Manufacturer:

PHARMARESEARCH CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 5, 2021

LMA Flexible Single Use

Manufacturer:

PLAXTRON INDUSTRIAL (M) SDN., BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2021

ARROW® Two-Lumen Central Venous Catheterization Set with Blue FlexTip® Catheter

Manufacturer:

ARROW INTERNACIONAL DE CHIHUAHUA S.A DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 2, 2021

ARROW® PICC with Chlorag+ard® Technology

Manufacturer:

ARROW INTERNACIONAL DE CHIHUAHUA S.A DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 2, 2021

ARROW Pediatric Two-Lumen Hemodialysis Catheterization Set with Blue FlexTip® Catheter

Manufacturer:

ARROW INTERNATIONAL C.R. A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 2, 2021

ARROW Large-Bore Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter

Manufacturer:

ARROW INTERNATIONAL CR, A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 1, 2021

ARROW Pressure Injectable PICC Set

Manufacturer:

ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 30, 2021

LMA Proseal

Manufacturer:

PARKER HANNIFIN CSS MERRILLVILLE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 29, 2021

ARROW YOU-BEND Two Lumen Hemodialysis Catheterization Set with Blue FlexTip ARROWg+ard Blue Catheter

Manufacturer:

ARROW INTERNATIONAL C.R. A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 28, 2021

ARROW® Central Venous Catheterization Set

Manufacturer:

ARROW INTERNACIONAL DE CHIHUAHUA S.A DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 27, 2021

ARROW Two Lumen Central Venous Catheterization Set with Blue FlexTip Catheter

Manufacturer:

ARROW INTERNATIONAL CR, A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 27, 2021

ARROW Double Lumen Central Venous Catheter Set with Blue Flex Tip ARROWg+ard Blue

Manufacturer:

ARROW INTERNATIONAL CR, A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2021

ARROW-CLARK VECTORFLOW Antegrade Hemodialysis Catheterization Set

Manufacturer:

ARROW INTERNACIONAL DE CHIHUAHUA S.A DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 20, 2021

ARROW Multi-Lumen Central Venous Catheterization Set With Blue Flextip® ARROWg+ard Blue® Catheter

Manufacturer:

ARROW INTERNATIONAL CR. A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 20, 2021

ARROW Two Lumen Hemodialysis Catheterization Set with Blue FlexTip® Catheter

Manufacturer:

ARROW INTERNATIONAL C.R. A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 19, 2021

PORTEX Suction Catheter

Manufacturer:

SMITHS HEALTHCARE MANUFACTURING SA DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2021

ILLUCO Dermatoscope

Manufacturer:

ILLUCO CORPORATION LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 28, 2021

KERMAX Plus DAP Meter

Manufacturer:

IBA DOSIMETRY GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 16, 2021

RESPOKARE N95 Respirator Plus

Manufacturer:

INNONIX TECHNOLOGIES (SHENZHEN) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 24, 2021

ZOONO Z-71 MICROBE SHIELD

Manufacturer:

JAYCHEM INDUSTRIES LTD. TO ZOONO GROUP LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2021

CADD Extension Set

Manufacturer:

SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 21, 2021

REDAX DRENTECH COMPACT Thoracic Drainage System

Manufacturer:

REDAX S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 17, 2021

REDAX Drentech Unico Percutaneous Drainage Kit 'MULTI"

Manufacturer:

REDAX S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 10, 2021

REDAX Connectors

Manufacturer:

REDAX S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 5, 2021

REDAX Heimlich Valve

Manufacturer:

REDAX S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 4, 2021

REDAX Drentech Unico Percutaneous Drainage Kit

Manufacturer:

REDAX S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 3, 2021

REDAX Thoracic Catheter Angled

Manufacturer:

REDAX S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 1, 2021

SYLFIRM ™

Manufacturer:

VIOL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 1, 2021

REDAX Thoracic Catheter Straight

Manufacturer:

REDAX S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 1, 2021

REDAX Drainage Bag

Manufacturer:

REDAX S.P.A.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 1, 2021

REDAX DRENTECH Compact Thoracic Drainage System

Manufacturer:

REDAX S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 26, 2021

REDAX Trocar Catheter

Manufacturer:

REDAX S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 26, 2021

FUKUDA DENSHI Electrocardiograph

Manufacturer:

FUKUDA DENSHI CO., LTD. SHIROI FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 20, 2021

SYRIS v900L Visualization System

Manufacturer:

ENERCON TECHNOLOGIES

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 18, 2021

FUKUDA DENSHI Digital Holter Recorder Digital Walk

Manufacturer:

FUKUDA DENSHI CO., LTD. SHIROI FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 17, 2021

FUKUDA DENSHI Electrocardiograph

Manufacturer:

FUKUDA DENSHI CO., LTD. SHIROI FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 17, 2021

FUKUDA DENSHI Advanced Electrocardiograph

Manufacturer:

FUKUDA DENSHI CO., LTD. SHIROI FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 17, 2021

FUKUDA DENSHI Electrocardiograph

Manufacturer:

FUKUDA DENSHI CO., LTD. SHIROI FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 17, 2021

FUKUDA DENSHI Advanced Electrocardiograph

Manufacturer:

FUKUDA DENSHI CO., LTD SHIROI FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2021

FUKUDA DENSHI Advanced Electrocardiograph

Manufacturer:

FUKUDA DENSHI CO., LTD. SHIROI FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2021

SLE 1000 nCPAP Generator Prongs and Accessories

Manufacturer:

SLE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2021

FUKUDA DENSHI Electrocardiograph (12-Electrocardiograph)

Manufacturer:

FUKUDA DENSHI CO., LTD. SHIROI FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2021

FUKUDA DENSHI Sphygmomanometer & Sphygmograph

Manufacturer:

FUKUDA DENSHI CO., LTD SHIROI FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 6, 2021

PORTEX Cuff Inflator/Pressure Gauge

Manufacturer:

VBM MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 3, 2021

FUKUDA DENSHI Advanced Electrocardiograph

Manufacturer:

FUKUDA DENSHI CO., LTD. SHIROI FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 1, 2021

TRUSCULPT iD Medical System

Manufacturer:

CUTERA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 8, 2021

PORTEX Guedel Airway

Manufacturer:

WELL LEAD MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 4, 2021

PORTEX Tracheal Tube

Manufacturer:

JIANGSU IAWA BIOSCIENCE ENGINEERING CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 15, 2020

CADD™ Medication Cassette Reservoir

Manufacturer:

SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2020

PORT-A-CATH II Low Profile Polysulfone/Titanium Venous Access System

Manufacturer:

SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2020

CADD-Legacy PCA Ambulatory Infusion Pump

Manufacturer:

SMITHS MEDICAL ASD INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 10, 2020

GRIPPER Needle

Manufacturer:

SMITHS HEALTHCARE MANUFACTURING SA DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 7, 2020

CUTERA TruSculpt Flex Powered Muscle Stimulator

Manufacturer:

JOHARI DIGITAL HEALTHCARE LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 7, 2020

GRIPPER Plus

Manufacturer:

SMITHS HEALTHCARE MANUFACTURING SA DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 7, 2020

NEUROLIGHT Portable Pupillometer

Manufacturer:

IDMED

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 10, 2020

RESPOKARE Anti-Viral Mask

Manufacturer:

INNONIX TECHNOLOGIES (SHENZHEN) CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 29, 2020

IDMED - AlgiScan Pupillary Algesimeter

Manufacturer:

IDMED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 8, 2020

IDMED - NeuroLight Portable Pupillometer

Manufacturer:

IDMED.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 8, 2020

PORTEX Tracheal Tube Accessories

Manufacturer:

SMITHS MEDICAL INTERNATIONAL LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 13, 2020

PORTEX Thermovent T2 HME

Manufacturer:

SMITHS MEDICAL INTERNATIONAL LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 8, 2020

PORTEX Reinforced ET Tubes, Single Use

Manufacturer:

SMITHS MEDICAL INTERNATIONAL LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2020

PORTEX Thoracic Catheter

Manufacturer:

SMITHS HEALTHCARE MANUFACTURING SA DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 2, 2020

CHEST Spirometry System

Manufacturer:

CHEST MIYAGI FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 18, 2020

PORTEX Blue Line Ultra Percutaneous Tracheostomy Kit

Manufacturer:

SMITHS MEDICAL CZECH REPUBLIC A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 6, 2020

PORTEX Epidural Minipack System 1

Manufacturer:

SMITHS MEDICAL CZECH REPUBLIC A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 4, 2020

PORTEX Emergency Cricothyroidotomy Kit

Manufacturer:

SMITHS MEDICAL CZECH REPUBLIC A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 24, 2020

PORTEX Blue Line SACETT Suction Above The Cuff

Manufacturer:

SMITHS HEALTHCARE MANUFACTURING SA DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 27, 2020

PORTEX Percutaneous Tracheostomy Kit

Manufacturer:

SMITHS MEDICAL INTERNATIONAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 27, 2020

SMITHS Portex Suction Pro 72

Manufacturer:

SMITHS HEALTHCARE MANUFACTURING SA DE C.V .

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 27, 2020

PORTEX Blue Line Tracheostomy Tube

Manufacturer:

SMITHS HEALTHCARE MANUFACTURING SA DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 24, 2020

PORTEX BLUE LINE ULTRA SUCTIONAID Tracheostomy Kit

Manufacturer:

SMITHS MEDICAL CZECH REPUBLIC A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 24, 2020

PORTEX BLUE LINE ULTRA Tracheostomy Kit

Manufacturer:

SMITHS MEDICAL CZECH REPUBLIC A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 24, 2020

PORTEX Minitracheostomy Kit

Manufacturer:

SMITHS MEDICAL INTERNATIONAL LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 23, 2020

PORTEX Blue Line Manometer Connecting Tube

Manufacturer:

SMITHS HEALTHCARE MANUFACTURING SA DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 21, 2020

PLURITEX RTT REUSABLE 3PC JUMPSUIT

Manufacturer:

PLURITEX S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 15, 2020

PORTEX Pleura Catheter with Flexible Introducer

Manufacturer:

SMITHS HEALTHCARE MANUFACTURING SA DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 14, 2020

PORTEX Tracheal Tube

Manufacturer:

SMITHS HEALTHCARE MANUFACTURING SA DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 11, 2020

PORTEX Polar Preformed Tracheal Tube

Manufacturer:

SMITHS HEALTHCARE MANUFACTURING SA DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 9, 2020

PORTEX® POLAR™ Preformed Tracheal Tube (Uncuffed)

Manufacturer:

SMITHS HEALTHCARE MANUFACTURING SA DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 9, 2020

PORTEX® Reinforced Tracheal Tube ( Uncuffed )

Manufacturer:

SMITHS HEALTHCARE MANUFACTURING SA DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 8, 2020

PORTEX® Tracheal Tube ( Uncuffed )

Manufacturer:

SMITHS HEALTHCARE MANUFACTURING SA DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 2, 2020

SUNTECH TANGO M2 Automatic Blood Pressure and Oxygen Saturation Measurement System

Manufacturer:

SUNTECH MEDICAL DEVICE (SHENZHEN) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 20, 2019

COSMOSOFT BodySculptor

Manufacturer:

PHYSIOMEDICA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 20, 2019

DERMAPEN 4 - Electronic cosmetic microneedling handpiece

Manufacturer:

PLANET INNOVATION PRODUCTS PTY LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2019

HIRONIC DOUBLO-GOLD

Manufacturer:

HIRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 5, 2019

YVOIRE Classic Plus

Manufacturer:

LG CHEM, LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 7, 2019

YSEE Volume Plus

Manufacturer:

LG CHEM, LTD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 24, 2019

YVOIRE Contour

Manufacturer:

LG CHEM, LTD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 23, 2019

COSMOSOFT ReduStim

Manufacturer:

COSMOSOFT S.A.S

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2019

COSMOSOFT ReduStim SP

Manufacturer:

COSMOSOFT S.A.S

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2019

INNOQ Disposable Electrode

Manufacturer:

SHANGHAI INTCO ELECTRODE MANUFACTURING CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 6, 2019

M-TECHNOLOGY Automatic Endoscope Washer & Disinfector

Manufacturer:

M-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 25, 2019

INNOQ Self - Sealing Sterilization Pouch

Manufacturer:

SHANGHAI JIANZHONG MEDICAL PACKAGING CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 4, 2019

Data sourced from BPOM (Badan Pengawas Obat dan Makanan), Indonesia.

Last updated: December 2025