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PT. DEMKA SAKTI

Authorized Representative in Indonesia

JLN. TANAH ABANG III/19 A-B, RT.002/RW.003
195 Products Represented
72 Manufacturers
Total Products
195
Manufacturers
72
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
77 products
39.5%
Kelas Resiko : B
93 products
47.7%
Kelas Resiko : C
22 products
11.3%
Kelas Resiko : D
3 products
1.5%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (195)
Complete portfolio registered with BPOM

DIRECTCHECK Whole Blood Controls

Manufacturer:

ACCRIVA DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 11, 2024

ADVANCED Insufflation Filter with Tubing Set

Manufacturer:

ADVANCED MEDICAL DESIGN.,CO. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 22, 2024

HEMOCHRON PT Cuvettes

Manufacturer:

ACCRIVA DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 18, 2024

HEMOCHRON ACT+ Cuvettes

Manufacturer:

ACCRIVA DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 17, 2024

Vyntus Pneumo

Manufacturer:

VYAIRE MEDICAL GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

BRUMABA CL-GENIUS Operating Table

Manufacturer:

BRUMABA GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 14, 2024

MEDIHONEY Antibacterial Wound Gel Dressing

Manufacturer:

DERMA SCIENCES,INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 14, 2024

MEDIHONEY Paste

Manufacturer:

DERMA SCIENCES INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 13, 2024

MEDIHONEY HCS-Hydrogel Colloidal Sheet with Antibacterial Honey

Manufacturer:

DERMA SCIENCES, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2024

ALTUS Operating Lamp

Manufacturer:

ST FRANCIS MEDICAL EQUIPMENT CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 23, 2024

ALTUS Operating Lamp

Manufacturer:

ST FRANCIS MEDICAL EQUIPMENT CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 23, 2024

ST FRANCIS OPERATING TABLE

Manufacturer:

ST FRANCIS MEDICAL EQUIPMENT CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 23, 2024

ALTUS Operating Lamp

Manufacturer:

ST. FRANCIS MEDICAL EQUIPMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 23, 2024

ST FRANCIS Operating Table

Manufacturer:

ST. FRANCIS MEDICAL EQUIPMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 17, 2024

ALTUS OMNI Patient Monitor

Manufacturer:

INFINIUM MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 27, 2024

ALTUS OMNI III Patient Monitor

Manufacturer:

INFINIUM MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 20, 2024

ALTUS OMNI II Touch Screen Patient Monitor

Manufacturer:

INFINIUM MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 15, 2024

GSI Shorts

Manufacturer:

DGS DIAGNOSTICS SP. Z O.O

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2024

BIOFLASH And Accesories

Manufacturer:

BIOKIT S.A.,A WERFEN COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 29, 2024

Aaron 1250S High Frequency Generator 100-240 Vac

Manufacturer:

BOVIE MEDICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 18, 2024

BOVIE BANTAM PRO Electrosurgical Generator + High Frequency Desiccator

Manufacturer:

BOVIE MEDICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2023

ACCUVEIN VEIN Illumination Device

Manufacturer:

ACCUVEIN LLC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 15, 2023

HUDSON & RCI Adaptor & Connectors

Manufacturer:

TELEFLEX MEDICAL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 11, 2023

BOVIE High Frequency Desiccator Monopolar/Bipolar

Manufacturer:

BOVIE MEDICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 7, 2023

HUDSON RCI Neonatal Conventional Circuit

Manufacturer:

TELEFLEX MEDICAL DE MEXICO S. DE R.L. DE C.V

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 16, 2023

HUDSON RCI Medium Concentration Oxygen Mask

Manufacturer:

TELEFLEX MEDICAL DE MEXICO, S. DE R.L. DE C.V.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 8, 2023

HUDSON RCI Voldyne Volumetric Exercise

Manufacturer:

TELEFLEX MEDICAL DE MEXICO,S.DE RL DE CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2023

KLOSURE

Manufacturer:

SURGINUS CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 2, 2023

HUDSON RCI Nonrebreathing Mask

Manufacturer:

TELEFLEX MEDICAL DEVICE MEXICO DE S.A DE C.V.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 30, 2023

OCTENILIN Wound Irrigation Solution

Manufacturer:

SCHULKE & MAYR GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 30, 2023

HUDSON RCI Nasal Cannula

Manufacturer:

TELEFLEX MEDICAL DE MEXICO S. DE RL. OF CV.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 26, 2023

HUDSON RCI Aquapak Bubble Humidifier & Accessories

Manufacturer:

MEDLINE INDUSTRIES - ARLINGTON HEIGHTS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 17, 2023

GIGASEPT PAA

Manufacturer:

BIOXAL Ltd.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 5, 2023

MINGJI Disposable Nasal Oxygen Cannula

Manufacturer:

SUZHOU NEW AREA MINGJI MACROMOLECULE MEDICAL APPARATUS CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 26, 2023

BOVIE High Frequency Electrosurgical Generators and Accessories

Manufacturer:

BOVIE - BULGARIA LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 5, 2023

VELA Ventilator

Manufacturer:

VYAIRE MEDICAL INC. (PALM SPRINGS)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 8, 2023

INFANT FLOW SiPAP System

Manufacturer:

VYAIRE MEDICAL INC. (PALM SPRINGS)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 8, 2023

3100A High Frequency Oscillatory Ventilator

Manufacturer:

VYAIRE MEDICAL, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 3, 2023

AVEA Fan

Manufacturer:

VYAIRE MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 9, 2023

GSI AMTAS Automated Audiometry

Manufacturer:

DGS DIAGNOSTICS SP Z.O.O

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 27, 2023

MEDIAN Fetal Monitor

Manufacturer:

BISTOS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2023

QUANTA Lite® ACA IgM III

Manufacturer:

INOVA DIAGNOSTICS, INC A WERFEN COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2022

CODAN Syringe Pump

Manufacturer:

CODAN ARGUS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 12, 2022

ACCUVEIN AV500 Vein Visualization Instrument

Manufacturer:

BENCHMARK ELECTRONICS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 17, 2022

pNEUTON S Ventilator

Manufacturer:

AIRON CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 13, 2022

MACS CPAP System

Manufacturer:

AIRON CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 31, 2022

pNEUTON Model A Ventilator

Manufacturer:

AIRON CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 31, 2022

pNEUTON Mini Ventilator

Manufacturer:

AIRON CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 31, 2022

FORTUS Sectio Caesarean Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 27, 2022

FORTUS Infant Laparatomy Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 27, 2022

FORTUS Scalpel Handle, Blades

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 17, 2022

MICROSHIELD 4

Manufacturer:

NAGINDAS HIRALAL BHAYANI

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2022

FORTUS Vena Section Instruments Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 12, 2022

FORTUS Tonsilectomy Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 12, 2022

FORTUS Suture Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 12, 2022

FORTUS Tracheotomy Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 12, 2022

FORTUS Partus Instruments Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 5, 2022

FORTUS Needle Holder

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 3, 2022

FORTUS Polypus Dressing Sponge Holding Forceps

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 29, 2022

QUANTA LITE ß2GPI IgM ELISA

Manufacturer:

INOVA DIAGNOSTICS, INC A WERFEN COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 29, 2022

FORTUS Orthopedic Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 27, 2022

FORTUS Obgyn Instrument

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2022

FORTUS Pterygium

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 23, 2022

FORTUS Minor Basic Surgery Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 22, 2022

FORTUS Nasal Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 22, 2022

MEDIAN Defibrillator/Monitor

Manufacturer:

MEDIAN CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 13, 2022

HeartOn A15 Automated External Defibrillator

Manufacturer:

MEDIAN CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 9, 2022

FORTUS Laparatomy Instruments Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 25, 2022

FORTUS Micro Curretage Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

FORTUS Mayor Basic Surgery Instruments Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 20, 2022

FORTUS Embryotomy Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 19, 2022

FORTUS Basic Instrument Set for Obgyn

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 19, 2022

FORTUS Intubation Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 19, 2022

QUANTA Lite® ANA ELISA

Manufacturer:

INOVA DIAGNOSTICS, INC A WERFEN COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 15, 2022

FORTUS Herniotomy Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 12, 2022

FORTUS Hordeolum Set Instrument

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 12, 2022

FORTUS Hysterectomy Instrument

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 12, 2022

FORTUS Haemorrhoidectomy Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 12, 2022

QUANTA LITE® ß2GPI IgG ELISA

Manufacturer:

INOVA DIAGNOSTICS, INC A WERFEN COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 11, 2022

FORTUS Mastoidectomy Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 3, 2022

FORTUS Basic Orthophaedic Instruments Set Large

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 29, 2022

GIGASEPT INSTRU AF Instruments Disinfectant

Manufacturer:

SCHULKE & MAYR GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 28, 2022

FORTUS Debridement Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 28, 2022

FORTUS Catarac Set Instruments

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 28, 2022

FORTUS Dilatation and Curretage Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 28, 2022

FORTUS Curretage Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 27, 2022

GIGAZYME Enzymatric Cleaner

Manufacturer:

SCHULKE & MAYR GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 25, 2022

SCHULKE DESMANOL Pure Hand Rub

Manufacturer:

SCHULKE & MAYR GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 25, 2022

FORTUS Basic Orthopaedic Instrument Set Small

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 14, 2022

MIKROZID AF Liquid

Manufacturer:

SCHULKE & MAYR GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2022

FORTUS Basic Major Vaginal Repair Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 14, 2022

FORTUS Amputation Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 13, 2022

FORTUS Bandage Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 13, 2022

FORTUS Basic Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 13, 2022

FORTUS Appendectomy Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 13, 2022

QUANTA Lite® dsDNA ELISA

Manufacturer:

INOVA DIAGNOSTICS, INC A WERFEN COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2022

QUANTA Lite ACA IgG III

Manufacturer:

INOVA DIAGNOSTICS, INC A WERFEN COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2022

KAZAMA ENT Unit

Manufacturer:

KAZAMAENT CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 14, 2022

KAZAMA ENT Unit

Manufacturer:

KAZAMAENT CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 12, 2022

FORTUS Urology Instruments

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 13, 2022

Plus-Sed auto (No Vacuum Plastic Tubes)

Manufacturer:

AQUISEL, S.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 11, 2022

FORTUS Diagnostic Instrument Stethoscope Pinard

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 8, 2022

FORTUS Vasectomy Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 8, 2022

FORTUS Otology Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 8, 2022

FORTUS Diagnostic Instrument, Hammer

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 8, 2022

FORTUS Rhinology Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 7, 2022

FORTUS Probes

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 6, 2022

FORTUS Atrauma Forceps

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 5, 2022

FORTUS Craniotomy Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 5, 2022

FORTUS Scissors

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 2, 2022

GINEVRI Warming Lamps

Manufacturer:

GENEVA S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 1, 2022

FORTUS Instrument Sterilization Container

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 25, 2022

FORTUS Prostatectomy Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 24, 2022

FORTUS ENT Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 24, 2022

FORTUS Laminectomy Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 24, 2022

FORTUS Intestinal Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 23, 2022

FORTUS Hemostatic Forceps

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 23, 2022

FORTUS ENT Instrument Set

Manufacturer:

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 23, 2022

GINEVRI ELIOS Phototherapy and Heating Lamp

Manufacturer:

GENEVA S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 21, 2022

GINEVRI BABY SHUTTLE Transport Incubator

Manufacturer:

GENEVA S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2022

GINEVRI Neonatal Resuscitator

Manufacturer:

GENEVA S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 4, 2022

ALTUS Surgical Suction Unit

Manufacturer:

DOCTOR'S FRIEND MEDICAL INSTRUMENT.CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 25, 2022

GINEVRI POLY TREND Neonatal Incubator

Manufacturer:

GENEVA S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 24, 2022

GINEVRI ALHENA PLUS Infant Warmer

Manufacturer:

GENEVA S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 23, 2022

GINEVRI Infant Warmer

Manufacturer:

GINEVRI Ltd.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 23, 2022

ALTUS Surgical Suction Unit

Manufacturer:

DOCTOR'S FRIEND MEDICAL INSTRUMENT.CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 22, 2022

KUBOTA BenchTop Centrifuge

Manufacturer:

KUBOTA MANUFACTURING CORPORATION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 11, 2022

SEILER EVOLUTION ZOOM Medical Operating Microscope

Manufacturer:

SEILER INSTRUMENT & MANUFACTURING COMPANY, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 29, 2021

SEILER Colposcope

Manufacturer:

SEILER INSTRUMENT & MANUFACTURING COMPANY, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 24, 2021

SEILER Colposcope

Manufacturer:

SEILER INSTRUMENT & MANUFACTURING COMPANY, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2021

SEILER Colposcope

Manufacturer:

SEILER INSTRUMENT & MANUFACTURING COMPANY, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2021

SEILER Alpha Air 6 ENT Surgical Microscope

Manufacturer:

SEILER INSTRUMENT & MANUFACTURING COMPANY., INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 19, 2021

ALTUS Surgical & Gynecology Suction Unit

Manufacturer:

DOCTOR'S FRIEND MEDICAL INSTRUMENT.CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2021

KUBOTA Benchtop Centrifuge S700T Non-Refrigerated and Accessories

Manufacturer:

KUBOTA MANUFACTURING CORPORATION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 1, 2021

KUBOTA Benchtop Refrigerated Centrifuge

Manufacturer:

KUBOTA MANUFACTURING CORPORATION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 18, 2021

KUBOTA Table Top Micro Refrigerated Centrifuge and Accessories

Manufacturer:

KUBOTA MANUFACTURING CORPORATION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 15, 2021

KUBOTA High Capacity Table Top Centrifuge 8420 and

Manufacturer:

KUBOTA MANUFACTURING CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 15, 2021

TELEFLEX CORR-A-FLEX Tubing

Manufacturer:

TELEFLEX MEDICAL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 15, 2021

KUBOTA Benchtop Refrigerated Centrifuge S700TR and Accessories

Manufacturer:

KUBOTA MANUFACTURING CORPORATION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 15, 2021

HUDSON RCI SHERIDAN / HVT

Manufacturer:

HUDSON RESPIRATORY CARE TECATE S. DE R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 11, 2021

HUDSON RCI Aquapak Prefilled Reservoir And Nebulizer Adapter

Manufacturer:

TELEFLEX MEDICAL inc

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 11, 2021

KUBOTA Compact Table Top Micro Centrifuge 3300 and

Manufacturer:

KUBOTA MANUFACTURING CORPORATION.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 10, 2021

BRUMABA OP 02 VARIUS Operating Table

Manufacturer:

BRUMABA GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 10, 2021

HUDSON RCI Voldyne Volumetric Exercise

Manufacturer:

TELEFLEX MEDICAL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 7, 2021

HUDSON RCI Sheridan Soft-Tip

Manufacturer:

HUDSON RESPIRATORY CARE TECATE S DE RLDE CV.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2021

HUDSON RCI Sheridan Sher-I-Bronch

Manufacturer:

TELEFLEX MEDICAL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2021

HUDSON RCI SHERIDAN / SPIRAL FLEX

Manufacturer:

HUDSON RESPIRATORY CARE TECATE S. DE R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2021

THERMA NE Automatic ESR Analyzer

Manufacturer:

LINEAR CHEMICALS S.L.U

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 21, 2021

CLONATEST Deproteinization Solution

Manufacturer:

LINEAR CHEMICALS, S.L.U.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 15, 2021

CLONATEST Systemic Solution

Manufacturer:

LINEAR CHEMICALS, S.L.U.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 15, 2021

CLONATEST Extrawash Cuvettes Solution

Manufacturer:

LINEAR CHEMICALS, S.L.U.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 15, 2021

ZERONE Electrocardiograph

Manufacturer:

ZERONE CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 22, 2021

ZERONE Electrocardiograph

Manufacturer:

ZERONE CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 20, 2021

BRUMABA Operating Table Systems

Manufacturer:

BRUMABA GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 31, 2021

CODAN ARGUS Syringe Pump

Manufacturer:

CODAN ARGUS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 10, 2021

GSI AUDIOscreener+

Manufacturer:

DIAGNOSTIC GROUP LLC - DBA GRASON-STADLER.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 9, 2021

CODAN ARGUS Volumetric Infusion Pump

Manufacturer:

CODAN ARGUS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 3, 2021

CODAN ARGUS Infusion Pump

Manufacturer:

CODAN ARGUS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2021

GSI PELLO Audiometer

Manufacturer:

DIAGNOSTIC GROUP LLC - DBA GRASON-STADLER.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 22, 2021

GSI 39 Auto Tymp

Manufacturer:

DGS DIAGNOSTICS SP Z.O.O.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 16, 2021

GSI Audera

Manufacturer:

DIAGNOSTIC GROUP LLC - DBA GRASON-STADLER

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 13, 2021

GSI Audera ASSR

Manufacturer:

DGS Diagnostics SP. Z.o.o

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 13, 2021

GSI 18 Screening Audiometer

Manufacturer:

DGS DIAGNOSTICS SP Z.O.O.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 13, 2021

GSI Audera AEP/CAEP

Manufacturer:

DIAGNOSTIC GROUP LLC - DBA GRASON-STADLER

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 9, 2021

GSI Audera DPOAE

Manufacturer:

DIAGNOSTIC GROUP LLC - DBA GRASON-STADLER.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 9, 2021

GSI AudioStar Pro Clinical Audiometer

Manufacturer:

DIAGNOSTIC GROUP LLC - DBA GRASON-STADLER

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 9, 2021

GSI Novus AABR/OAE SCREENER

Manufacturer:

DGS DIAGNOSTICS SP Z.O.O.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2021

HEMOCHRON Response and Accessories

Manufacturer:

ACCRIVA DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 2, 2021

HEMOCHRON Celite ACT Tubes

Manufacturer:

ACCRIVA DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2021

AVOXIMETER 4000 Whole Blood CO-Oximeter and Accessories

Manufacturer:

ACCRIVA DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2021

ASETRONIC LED Examination Light

Manufacturer:

ASETRONIC ADVANCE SWISS ELECTRONICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 10, 2021

VADI AIRWAY CONNECTOR

Manufacturer:

VADI MEDICAL TECHNOLOGY CO LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 21, 2020

MEDIMA LINE Infusion Set

Manufacturer:

MEDIMA SP. Z O.O.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2020

VADI Breathing Circuit Bacterial Filter

Manufacturer:

VADI MEDICAL TECHNOLOGY CO LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 15, 2020

VADI Respiratory Humidifier

Manufacturer:

VADI MEDICAL TECHNOLOGY CO LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 15, 2020

MEDIMA LINE Infusion Set

Manufacturer:

MEDIMA SP. Z O.O.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2020

MEDIMA LINE Extension Line

Manufacturer:

MEDIMA SP. Z O.O.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2020

VADI Ventilator Tubing

Manufacturer:

VADI MEDICAL TECHNOLOGY CO., LTD., YANGMEI

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 13, 2020

MEDIMA LINE Infusion Set

Manufacturer:

MEDIMA SP. Z O.O.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 10, 2020

MEDIMA LINE Infusion Sets

Manufacturer:

MEDIMA SP. Z O.O.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 7, 2020

VADI Breathing Reservoir Bag

Manufacturer:

VADI MEDICAL TECHNOLOGY CO LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2020

MEDIMA LINE Infusion Set

Manufacturer:

MEDIMA SP. Z O.O.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 4, 2020

VADI Respiratory Humidifier

Manufacturer:

VADI MEDICAL TECHNOLOGY CO LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2020

GSI TYMPSTAR PRO Clinical Middle Ear Analyzer

Manufacturer:

GRASON-STADLER.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 15, 2020

MEDIMA Volumetric Infusion Pump

Manufacturer:

MEDIMA SP. Z O.O.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2020

MEDIMA Volumetric Infusion Pump

Manufacturer:

MEDIMA SP. Z O.O.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 13, 2020

MEDIMA Volumetric Infusion Pump

Manufacturer:

MEDIMA SP. Z O.O.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 13, 2020

MEDIMA Syringe Infusion Pumps

Manufacturer:

MEDIMA SP. Z O.O.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2020

MEDIMA Syringe Infusion Pump

Manufacturer:

MEDIMA SP. Z O.O.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 3, 2020

MEDIMA Syringe Infusion Pump

Manufacturer:

MEDIMA SP. Z O.O.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 2, 2020

MEDIMA Syringe Infusion Pump

Manufacturer:

MEDIMA SP. Z O.O.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 30, 2020

VADI Water Trap

Manufacturer:

VADI MEDICAL TECHNOLOGY CO. LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 20, 2020

GSI Allegro

Manufacturer:

DGS DIAGNOSTICS SP. Z O.O

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 1, 2019

PRECHEK Hepatitis B Virus Antigen Detected in Whole Blood (HbsAg)

Manufacturer:

ATLAS LINK TECHNOLOGY CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 14, 2019

GSI Shorts

Manufacturer:

DGS DIAGNOSTICS SP. Z O.O

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 6, 2019

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

Last updated: December 2025