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PT. FOCUS DIAGNOSTIC INDONESIA

Authorized Representative in Indonesia

Jl. Jatipadang Raya No.9A, RT.6/RW.4, Kelurahan Jatipadang, Kecamatan Pasar Minggu, Kota Jakarta Selatan, DKI Jakarta 12540
278 Products Represented
46 Manufacturers
Total Products
278
Manufacturers
46
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
92 products
33.1%
Kelas Resiko : B
147 products
52.9%
Kelas Resiko : C
37 products
13.3%
Kelas Resiko : D
2 products
0.7%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (278)
Complete portfolio registered with BPOM

FlowClean Cleaning Agent

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 5, 2025

FOKUS FDI HM-3 Plus Diluent Hematology Reagent

Manufacturer:

AEHEALTH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 5, 2025

FOKUS Auto 3-Diff Hematology Analyzer

Manufacturer:

AEHEALTH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 5, 2025

AQUIOS Cleaning Agent

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 4, 2025

FOCUS Leptospira IgM Cassette

Manufacturer:

ZEPHYR BIOMEDICALS - A DIV. OF TULIP DIAGNOSTICS (P) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 3, 2025

FOKUS FDI HM-5 Plus Diluent Hematology Reagent

Manufacturer:

AEHEALTH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 3, 2025

FOKUS FDI HM-5 Plus DIFF Lyse Hematology Reagent

Manufacturer:

AEHEALTH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 3, 2025

FOCUS Syphicheck WB device

Manufacturer:

ZEPHYR BIOMEDICALS - A DIV. OF TULIP DIAGNOSTICS (P) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 24, 2025

FOKUS Love-Gruenwald Laminectomy Rongeur Instrument

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH & CO. KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 14, 2025

FOKUS Measuring Instrument Set II

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 14, 2025

FOKUS Febrile Antigen H-A Paratyphi

Manufacturer:

PULSE SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 7, 2025

FOKUS Febrile Antigen O-A Paratyphi

Manufacturer:

PULSE SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2025

FOKUS Febrile Antigen O-C Paratyphi

Manufacturer:

PULSE SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2025

FOKUS Febrile Antigen H-B Paratyphi

Manufacturer:

PULSE SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2025

FOKUS Febrile Antigen H Typhi

Manufacturer:

PULSE SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2025

FOKUS Febrile Antigen H-C Paratyphi

Manufacturer:

PULSE SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2025

BECKMAN COULTER CD11c-PE

Manufacturer:

IMMUNOTECH S.A.S., A BECKMAN COULTER COMPANY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 26, 2024

FOKUS Sterilizing Boxes & Receptacles Instrument

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH & CO. KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2024

BECKMAN COULTER IgG2a(mouse)-APC

Manufacturer:

IMMUNOTECH S.A.S., A BECKMAN COULTER COMPANY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 23, 2024

BECKMAN COULTER CD64-FITC

Manufacturer:

IMMUNOTECH S.A.S., A BECKMAN COULTER COMPANY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 23, 2024

BECKMAN COULTER CD14-PE

Manufacturer:

IMMUNOTECH S.A.S., A BECKMAN COULTER COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2024

ClearLLab Compensation Kit

Manufacturer:

BECKMAN COULTER INDIA PRIVATE LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2024

ClearLLab LS Lymphoid Screen Reagent

Manufacturer:

BECKMAN COULTER INDIA PRIVATE LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2024

BECKMAN COULTER CD45 APC

Manufacturer:

IMMUNOTECH S.A.S., A BECKMAN COULTER COMPANY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 16, 2024

FOKUS Multi-Drug 6 Drugs Rapid Test Panel (AMP1000/BZO300/COC300/THC50/MET500/MOP300)

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 13, 2024

FOKUS FDI HM-5Plus LH lyse hematology reagent

Manufacturer:

AEHEALTH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2024

FOKUS Urine Sediment Negative Control

Manufacturer:

BIOWAY BIOLOGICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2024

FOKUS Auto 5-Diff Hematology Analyzer

Manufacturer:

AEHEALTH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2024

FOKUS Urine Sediment Positive Control

Manufacturer:

BIOWAY BIOLOGICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2024

FOKUS Sterilizing Forcep

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 13, 2024

FOCUS Obstetric Hook

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 11, 2024

FOCUS Implant Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 11, 2024

FOKUS IUD Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 11, 2024

CYTO-STAT triCHROME CD8-FITC/CD4-RD1/CD3-PC5

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 9, 2024

FOKUS Sterile Blood Collection Needles for single use

Manufacturer:

WEIHAI WEIGAO BLOOD COLLECTION SUPPLIES CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 7, 2024

UNITED IMAGING Digital Mammography X-ray Imaging System

Manufacturer:

SHANGHAI UNITED IMAGING HEALTHCARE CO,. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 20, 2024

COULTER CLONE T8-RD1

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 4, 2024

CYTO-STAT COULTER CLONE CD3 (IgG1)-FITC

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 4, 2024

FOKUS IL-6 (Interleukin- 6) Rapid Quantitative Test (Immunofluorescence Assay)

Manufacturer:

SHENZHEN AEHEALTH TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2024

FOKUS DIAGNOSTIC Urine Sediment Analyzer

Manufacturer:

BIOWAY BIOLOGICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 12, 2024

FOKUS T4 (Total Thyroxine) Rapid Quantitative Test (Immunofluorescence Assay)

Manufacturer:

SHENZHEN AEHEALTH TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 9, 2024

FOKUS T3 (Total Triiodothyronine) Rapid Quantitative Test (Immunofluorescence Assay)

Manufacturer:

SHENZHEN AEHEALTH TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 9, 2024

FOKUS MAU (Microalbumin) Rapid Quantitative Test (Immunofluorescence Assay)

Manufacturer:

SHENZHEN AEHEALTH TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 4, 2024

FOKUS HS-CRP/CRP (High Sensitivity C-reactive Protein/ C-reactive Protein) Rapid Quantitative Test (Immunofluorescence Assay)

Manufacturer:

SHENZHEN AEHEALTH TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 4, 2024

FOKUS cTnI (Cardiac Troponin I) Rapid Quantitative Test (Immunofluorescence Assay)

Manufacturer:

SHENZHEN AEHEALTH TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 4, 2024

FOKUS TSH (Thyroid Stimulating Hormone) Rapid Quantitative Test (Immunofluorescence Assay)

Manufacturer:

SHENZHEN AEHEALTH TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 4, 2024

FOKUS 25-(OH)-VD (25-OH Vitamin D) Rapid Quantitative Test (Immunofluorescence Assay)

Manufacturer:

SHENZHEN AEHEALTH TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 3, 2024

FOKUS High-pressure Angiographic Dual Syringe for Single Use and Accessory

Manufacturer:

SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 28, 2024

FOKUS PSA (Prostate Specific Antigen) Rapid Quantitative Test (Immunofluorescence Assay)

Manufacturer:

SHENZHEN AEHEALTH TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 28, 2024

FOKUS FT4 (Free Thyroxine) Rapid Quantitative Test (Immunofluorescence Assay)

Manufacturer:

SHENZHEN AEHEALTH TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 24, 2024

FOKUS High-pressure Angiographic Syringe for Single Use and Accessory

Manufacturer:

SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 19, 2024

FOKUS FT3 (Free Triiodothyronine) Rapid Quantitative Test (Immunofluorescence Assay)

Manufacturer:

SHENZHEN AEHEALTH TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 19, 2024

DxFLEX Daily QC Fluorospheres

Manufacturer:

BECKMAN COULTER, INC.,

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 19, 2024

FOKUS Micro Hematocrit and Micro Tubes Centrifuge

Manufacturer:

HUNAN LABWE SCIENTIFIC INSTRUMENTS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2024

FOKUS Benchtop Multi-pipe Centrifuge

Manufacturer:

HUNAN LABWE SCIENTIFIC INSTRUMENTS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2024

FOKUS Ferritin Rapid Quantitative Test

Manufacturer:

SHENZHEN AEHEALTH TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

XENTA D-Dimer Detection Kit (Fluorescent immune chromatography)

Manufacturer:

XENTA BIOMEDICAL SCIENCE CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

XENTA HbA1c Rapid Quantitative Test

Manufacturer:

XENTA BIOMEDICAL SCIENCE CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

FOKUS PCT (Procalcitonin) Rapid Quantitative Test (Immunofluorescence Assay)

Manufacturer:

SHENZHEN AEHEALTH TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

FOKUS HbA1c (Glycated Hemoglobin) Rapid Quantitative Test (Immunofluorescence Assay)

Manufacturer:

SHENZEN AEHEALTH TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

UNITED IMAGING Medical Linear Accelerator System

Manufacturer:

SHANGHAI UNITED IMAGING HEALTHCARE CO,. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 20, 2024

FOCUS Antistreptolysin-O (ASO) Latex Test

Manufacturer:

PULSE SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 3, 2024

FOKUS RPR Antigen Test

Manufacturer:

PULSE SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 29, 2024

FOKUS Medical Stretcher

Manufacturer:

JIANGSU SAIKANG MEDICAL EQUIPMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 23, 2024

FOKUS Gynecology Operating Bed

Manufacturer:

JIANGSU SAIKANG MEDICAL EQUIPMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 23, 2024

FOCUS Operating Table

Manufacturer:

JIANGSU SAIKANG MEDICAL EQUIPMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 23, 2024

QuickCOMP 4 Regent Kit

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

IOTest CD4 PC7

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 3, 2024

FOKUS cTnT (Cardiac troponin T) Rapid Quantitative Test (Immunofluorescence Assay)

Manufacturer:

SHENZHEN AEHEALTH TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 25, 2024

BECKMAN COULTER CD8-FITC

Manufacturer:

IMMUNOTECH S.A.S., A BECKMAN COULTER COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 25, 2024

BECKMAN COULTER CD8-PC5

Manufacturer:

IMMUNOTECH S.A.S., A BECKMAN COULTER COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2024

FOKUS FSH (Follicle-Stimulating Hormone) Rapid Quantitative Test (Immunofluorescence Assay)

Manufacturer:

SHENZHEN AEHEALTH TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 19, 2024

IOTest CD8-PE

Manufacturer:

IMMUNOTECH S.A.S., A BECKMAN COULTER COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 19, 2024

FOKUS Fluorescence Immunoassay Analyzer (Immunofluorescence Chromatography) Model: Lamuno X

Manufacturer:

SHENZHEN AEHEALTH TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2024

FOKUS PRP/Portable Low Speed Centrifuge and Accessories

Manufacturer:

HUNAN LABWE SCIENTIFIC INSTRUMENTS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 7, 2024

BECKMAN COULTER CD8-APC

Manufacturer:

IMMUNOTECH S.A.S., A BECKMAN COULTER COMPANY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 6, 2024

FOKUS Mini Centrifuge TD4M and accessories

Manufacturer:

HUNAN LABWE SCIENTIFIC INSTRUMENTS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 5, 2024

FOKUS D-Dimer Rapid Quantitative Test (Immunofluorescence Assay)

Manufacturer:

SHENZEN AEHEALTH TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 5, 2024

FOKUS LH (Luteinizing Hormone) Rapid Quantitative Test (Immunofluorescence Assay)

Manufacturer:

SHENZHEN AEHEALTH TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 26, 2024

FOKUS AFP (Alpha-Fetoprotein) Rapid Quantitative Test (Immunofluorescence Assay)

Manufacturer:

SHENZHEN AEHEALTH TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 23, 2024

FOKUS β-HCG (β-Human Chorionic Gonadotropin) Rapid Quantitative Test (Immunofluorescence Assay)

Manufacturer:

SHENZHEN AEHEALTH TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 18, 2024

BECKMAN COULTER Cyto-Stat/COULTER CLONE T4-RD1/T8-FITC

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 9, 2024

BECKMAN COULTER CYTO-STAT/COULTER CLONE T4 - FITC

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 5, 2024

BECKMAN COULTER CYTO-STAT triCHROME CD45-FITC/CD4-RD/CD3-PC5

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2024

COULTER CYTO-TROL Control Cells Kit

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2024

BECKMAN COULTER CYTO-COMP Cell Kit

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2024

FOKUS Cocaine (COC) Cassette

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 29, 2023

FOKUS Marijuana (THC) Cassette

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 29, 2023

FOKUS Benzodiazepine (BZD) Cassette

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 28, 2023

FOCUS Amphetamines (AMP) Cassette

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 28, 2023

FOKUS Methamphetamine (M-AMP) Cassette

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 28, 2023

FOKUS Morphine (Opiates) Rapid Test

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 28, 2023

FOKUS 10 in 1 DOA Cassette (AMP1000/BZD300/CAR2000/COC300/ETG500/MET1000/MOP300/PCP25/K250/THC50)

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 21, 2023

FOCUS 5 in 1 DOA Cassette (AMP-1000, BZD-300, THC-50, MET-1000, MOP-300)

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 14, 2023

FOKUS 3 in 1 DOA Cassette (AMP-1000, MOP-2000, THC-50)

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 14, 2023

FOCUS DS5 Semi - Auto Chemistry Analyzer

Manufacturer:

SHENZEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 13, 2023

FOKUS DS7 Fully Auto Chemistry Analyzer

Manufacturer:

SHENZEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2023

FOKUS Hemoglobin Test Kit (Chromatography)

Manufacturer:

SHENZHEN AEHEALTH TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2023

FOKUS High Speed Centrifuge

Manufacturer:

HUNAN LABWE SCIENTIFIC INSTRUMENTS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 4, 2023

FOKUS Refrigerated centrifuge

Manufacturer:

HUNAN LABWE SCIENTIFIC INSTRUMENTS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 30, 2023

FOKUS Blood ID Centrifuge

Manufacturer:

HUNAN LABWE SCIENTIFIC INSTRUMENTS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 29, 2023

FOKUS α -Amylase (AMY/Enzymatic)

Manufacturer:

SHENZEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 27, 2023

FOKUS Creatinine Kinase-MB (CK-MB/Selective Inhibition)

Manufacturer:

SHENZEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2023

FOKUS Widal Negative Control

Manufacturer:

TULIP DIAGNOSTICS PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2023

FOCUS ENT Instruments Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 27, 2023

FOKUS Episiotomy Instrument Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 27, 2023

FOCUS Gastrointestinal Instrument Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 25, 2023

FOKUS Diagnostic Instrument Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 20, 2023

FOKUS Neurosurgery Instrument Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 20, 2023

I-SPOT.TB

Manufacturer:

SHANGHAI FOSUN LONG MARCH MEDICAL SCIENCE CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 18, 2023

FOKUS Cardiovascular Surgical Instrument Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 17, 2023

FOKUS Salpingostomy Instrument Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 16, 2023

FOKUS Abdominal Instrument Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 16, 2023

FOKUS Cervical Biopsy Instrument Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 16, 2023

IMMUNO-TROL Low Cells

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 22, 2023

FOKUS CEA (Carcino-Embryonic Antigen) Rapid Quantitative Test (Immunofluorescence Assay)

Manufacturer:

SHENZHEN AEHEALTH TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 22, 2023

FOKUS Urine Test Strip

Manufacturer:

BIOWAY BIOLOGICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 18, 2023

FOCUS Scissors Instrument Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 18, 2023

FOKUS Urine Test Strip

Manufacturer:

BIOWAY BIOLOGICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 18, 2023

FOKUS Tissue and Organ Holding Forceps Instrument

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 15, 2023

FOKUS Needle Holders Instrument Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 15, 2023

FOKUS CK-MB (Creatine Kinase MB) Rapid Quantitative Test (Immunofluorescence Assay)

Manufacturer:

SHENZHEN AEHEALTH TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 13, 2023

FOKUS Hemoglobin analyzer (Chromatography)

Manufacturer:

SHENZHEN AEHEALTH TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 13, 2023

FOKUS Bone Surgery Instruments Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 11, 2023

FOKUS Screw Drivers and Radolf Nail Instrument

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 11, 2023

FOCUS Trocars, Suction Tubes Instrument

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 11, 2023

FOCUS Urine Test Strip URS-3

Manufacturer:

BIOWAY BIOLOGICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2023

FOCUS Urine Test Strip URS-1

Manufacturer:

BIOWAY BIOLOGICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2023

ClearLLab 10C M2 Cell Tube

Manufacturer:

BECKMAN COULTER INDIA PRIVATE LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2023

FOKUS Dittel Dilating and Catheter Introducing Instrument

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 5, 2023

FOKUS Swab Dressing Forceps Instrument

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 29, 2023

FOKUS Gall, Liver, Kidney, Bladder, Urology Instrument

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 28, 2023

FOKUS Burns and Casper Bone Curettes Instrument

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 28, 2023

ClearLLab 10C M1 Cell Tube

Manufacturer:

BECKMAN COULTER INDIA PRIVATE LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 23, 2023

FOKUS Urine Test Strip

Manufacturer:

BIOWAY BIOLOGICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 15, 2023

FOKUS Urine Test Strip

Manufacturer:

BIOWAY BIOLOGICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 15, 2023

ClearLLab 10C B Cell Tube

Manufacturer:

BECKMAN COULTER INDIA PRIVATE LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 14, 2023

FOKUS Multiple Drug -3 Combo Cassette (AMP/OPI/THC)

Manufacturer:

LUMIQUICK DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 1, 2023

FOKUS Urine QC Positive Control Set

Manufacturer:

BIOWAY BIOLOGICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 18, 2023

FOKUS Urine QC Negative Control Set

Manufacturer:

BIOWAY BIOLOGICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 17, 2023

CS tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 Monoclonal Antibodies

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 13, 2023

IMMUNO-TROL Cells

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 12, 2023

FOKUS FOB Rapid Test Cassette

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2023

FOKUS Methamphetamine (M-AMP) Cassette

Manufacturer:

LUMIQUICK DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2023

FOKUS hCG Pregnancy Rapid Test Dipstick

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2023

FOKUS hCG Pregnancy Rapid Test Cassette

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2023

ClearLLab Compensation Beads

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 4, 2023

FOKUS Direct Bilirubin (D- Bil/VOX)

Manufacturer:

SHENZHEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 30, 2023

FOKUS y-Glutamyl Transferase (y-GT/GGT/GPNA Substrase)

Manufacturer:

SHENZHEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 19, 2023

FOKUS Creatinine Kinase-NAC (CK-NAC/Creatinine Phosphatase Substrate)

Manufacturer:

SHENZHEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 16, 2023

FOKUS Opiates (OPI) Cassette - 300 ng/mL

Manufacturer:

LUMIQUICK DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 29, 2023

FOKUS Cocaine (COC) Cassette

Manufacturer:

LUMIQUICK DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 29, 2023

FOKUS Marijuana (THC) Cassette

Manufacturer:

LUMIQUICK DIAGNOSTIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 24, 2023

FOKUS Benzodiazepine (BZD) Cassette

Manufacturer:

LUMIQUICK DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2023

FOCUS Cholinesterase (CHE/DGKC)

Manufacturer:

SHENZHEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 16, 2023

FOCUS Amphetamines (AMP) Cassette

Manufacturer:

LUMIQUICK DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 12, 2023

FOCUS Total Protein (TP/Biuret)

Manufacturer:

SHENZHEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2023

FOKUS Albumin (ALB/BCG)

Manufacturer:

SHENZHEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 26, 2023

AQUIOS Flow-Count Fluorospheres

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

AQUIOS Lysing Reagent Kit

Manufacturer:

CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 30, 2023

XENTA Fluorescent Immuno-Analyzer X-FIA-300

Manufacturer:

XENTA BIOMEDICAL SCIENCE CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 24, 2023

FOKUS RF Latex

Manufacturer:

PULSE SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 22, 2023

XENTA TB Specific Cell Immune Response Detection kit

Manufacturer:

XENTA BIOMEDICAL SCIENCE CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 22, 2023

FOKUS CRP Latex Test

Manufacturer:

PULSE SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2023

FOKUS DIAGNOSTIC Urine Analyzer and Accessories

Manufacturer:

BIOWAY BIOLOGICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 1, 2023

FOCUS Urine Test Strip URS-10H

Manufacturer:

BIOWAY BIOLOGICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 15, 2023

Flow-Set Pro Fluorospheres

Manufacturer:

BECKMAN COULTER, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2023

FOKUS Anti - HCV Cassette

Manufacturer:

NEWSCEN COAST BIO-PHARMACEUTICAL CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 1, 2023

FOKUS Anti - HCV Strip

Manufacturer:

NEWSCEN COAST BIO-PHARMACETICAL CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 1, 2023

BECKMAN Flow-Check Pro Fluorospheres

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

FOKUS FDI-HM-3 Plus Lyse Hematology Reagent

Manufacturer:

SHENZHEN AEHEALTH TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

FOKUS FDI-HM-3 Plus Hematology Analyzer Probe Cleanser

Manufacturer:

SHENZHEN AEHEALTH TECHNOLOGY CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 26, 2022

FOKUS Gynecology Obstetrics Instrument Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH & CO. KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2022

FOKUS Probes Instrument Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 24, 2022

FOKUS General Instrument Set II

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 22, 2022

FOKUS Hooks-Blades Spatulas

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 16, 2022

FOKUS Measuring Instruments set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 16, 2022

FOCUS Tonsillectomy Instrument

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 16, 2022

FOKUS General Instrument Set I

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 16, 2022

FOKUS Rectal Spectula and Rectoscope Instrument

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 16, 2022

AQUIOS Tetra-1 Panel

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2022

FOCUS Pituitary Instruments

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 4, 2022

FOCUS Anesthesia Instrument

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 4, 2022

FOKUS Forceps Instrument Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 4, 2022

FOKUS Ferris-Smith Laminectomy Forceps Rongeur Instrument

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 3, 2022

FOCUS Hemolysis

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 26, 2022

FOCUS Diluent-3

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 6, 2022

FOKUS Basic Plastic Surgery Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 28, 2022

FOCUS Emergency Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 28, 2022

FOCUS Orthopedic Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 26, 2022

FOCUS Nephrolithotomy Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 26, 2022

FOKUS Neurosurgical Instrument

Manufacturer:

CEATEC MEDIZINTECHNIIK GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 26, 2022

FOKUS Micro Instruments

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 26, 2022

FOKUS Thoracotomy Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 26, 2022

FOCUS Supercut Scissors Instruments

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 22, 2022

FOKUS Gruenwald Rodent Instrument

Manufacturer:

CEATEC MEDIZINTECHNIIK GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 22, 2022

FOCUS Caspar Rongeur Instrument

Manufacturer:

CEATEC MEDIZINTECHNIIK GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 21, 2022

FOKUS Retractors Instrument Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH. & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 19, 2022

FOKUS Kerrison-Laminectomy Punches Instrument

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH & CO. KG

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 19, 2022

FOKUS Billy II - Rongeur Instrument

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 19, 2022

FOKUS Peapod Rodent Instrument

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 14, 2022

FOKUS Artery Forceps Instrument Set

Manufacturer:

CEATEC MEDIZINTECHNIIK GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 8, 2022

FOKUS Various Articles Instrument

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 8, 2022

FOKUS Head-Cranio Instruments

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH & CO. KG

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 8, 2022

FOKUS Spine Instrument

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 6, 2022

FOKUS Cardiovascular Surgery Instrument Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH & CO. KG

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 6, 2022

FOCUS Lipase (LPS/Methyl halogen test)

Manufacturer:

SHENZEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2022

AQUIOS CL Flow Cytometer

Manufacturer:

BECKMAN COULTER INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

AQUIOS Tetra-2+ Panel

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 16, 2022

AQUIOS Sheath Solution

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 16, 2022

FOKUS Low Density Lipoprotein Cholesterol (LDL-C/Direct)

Manufacturer:

SHENZEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

FOKUS Total Cholesterol (CHO/CHOD-PAP)

Manufacturer:

SHENZEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

FOCUS 6 PRAYER

Manufacturer:

TULIP DIAGNOSTICS PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 12, 2022

DxFLEX Sheath Fluid

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 9, 2022

AQUIOS IMMUNO-TROL Cells

Manufacturer:

BECKMAN COULTER, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 9, 2022

FOKUS Creatinine (Enzyme)

Manufacturer:

SHENZEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 27, 2022

FOKUS Glutamate Oxaloacetate Transaminase (AST/IFCC)

Manufacturer:

SHENZEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 18, 2022

FOKUS Glutamate Pyruvate Transaminase (ALT/IFCC)

Manufacturer:

SHENZEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 18, 2022

FOCUS Total Bilirubin (TBil)/VOX)

Manufacturer:

SHENZEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 15, 2022

FOKUS Urea (Enzymatic)

Manufacturer:

SHENZEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 15, 2022

FOKUS Alkaline Phospatase (ALP/IFCC)

Manufacturer:

SHENZEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2022

FOKUS Glucose (GLU/GOD-PAP)

Manufacturer:

SHENZEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 11, 2022

FOKUS Obstetric Surgical Instrument Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 30, 2022

FOKUS High Density Lipoprotein Cholesterol (HDL-C/Direct)

Manufacturer:

SHENZEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2022

FOKUS Triglyceride (TG/GPO-PAP)

Manufacturer:

SHENZEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2022

FOCUS Widal Positive Control

Manufacturer:

TULIP DIAGNOSTICS PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2022

FOKUS Malaria Falcivax Pv/Pf Cassette

Manufacturer:

ZEPHYR BIOMEDICALS - A DIV. OF TULIP DIAGNOSTICS (P) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2022

FOCUS S. Typhi 'H' Antigen

Manufacturer:

TULIP DIAGNOSTICS PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 24, 2022

FOCUS Malaria Parascreen PAN/Pf Cassette

Manufacturer:

ZEPHYR BIOMEDICALS - A DIV. OF TULIP DIAGNOSTICS (P) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2022

FOCUS S. Typhi 'O' Antigen

Manufacturer:

TULIP DIAGNOSTICS PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 19, 2022

FOKUS S. Paratyphi 'AO' Antigen

Manufacturer:

TULIP DIAGNOSTICS PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 19, 2022

FOCUS Salmonella Typhi IgM Cassette

Manufacturer:

ZEPHYR BIOMEDICALS - A DIV. OF TULIP DIAGNOSTICS [P] LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 13, 2022

FOCUS Salmonella Typhi IgG/ IgM Cassette

Manufacturer:

ZEPHYR BIOMEDICALS - A DIV. OF TULIP DIAGNOSTICS [P] LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 10, 2022

FOKUS S. Paratyphi 'CH' Antigen

Manufacturer:

TULIP DIAGNOSTICS PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 10, 2022

FOKUS S. Paratyphi 'CO' Antigen

Manufacturer:

TULIP DIAGNOSTICS PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 19, 2022

FOKUS S. Paratyphi 'BO' Antigen

Manufacturer:

TULIP DIAGNOSTICS PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 11, 2022

FOKUS S. Paratyphi 'BH' Antigen

Manufacturer:

TULIP DIAGNOSTICS PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 8, 2022

FOCUS S. Paratyphi 'AH' Antigen

Manufacturer:

TULIP DIAGNOSTICS PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2022

FOKUS Bandage Instrument Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 30, 2022

FOKUS Hemorrhoidectomy Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 29, 2022

FOKUS Caesarean Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 29, 2022

FOCUS Mastoidectomy Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 29, 2022

FOCUS Partus Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 28, 2022

FOKUS Herniotomy Instrument Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 24, 2022

FOKUS Hysterectomy Vaginal Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 24, 2022

FOCUS Amputation Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 24, 2022

FOKUS Tracheotomy Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 24, 2022

FOKUS Appendectomy Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 23, 2022

FOCUS Embriotomy Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 21, 2022

FOCUS Laparatomy Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 21, 2022

FOCUS Dengue IgG/ IgM Cassette

Manufacturer:

ZEPHYR BIOMEDICALS - A DIV. OF TULIP DIAGNOSTICS (P) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 21, 2022

FOCUS Major Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 17, 2022

FOKUS Minor Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 17, 2022

FOKUS Vena C-section Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 17, 2022

FOCUS Circumsisi Set

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 16, 2022

FOKUS General Instrument Set III

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 25, 2022

FOKUS Scissors Instrument Set II

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 3, 2022

FOKUS hCG Cassette

Manufacturer:

GENIX TECHNOLOGY INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 24, 2021

FOKUS Gynecological Operating Bed

Manufacturer:

JIANGSU SAIKANG MEDICAL EQUIPMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 19, 2021

FOKUS Orthopedics Traction Bed

Manufacturer:

JIANGSU SAIKANG MEDICAL EQUIPMENT CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 18, 2021

FOKUS Patient Transportation Trolley

Manufacturer:

JIANGSU SAIKANG MEDICAL EQUIPMENT CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 18, 2021

FOKUS Medical Stretcher

Manufacturer:

JIANGSU SAIKANG MEDICAL EQUIPMENT CO., LTD..

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 6, 2021

FOCUS Operating Table

Manufacturer:

JIANGSU SAIKANG MEDICAL EQUIPMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 4, 2021

FOKUS Hydraulic Exam Table

Manufacturer:

JIANGSU SAIKANG MEDICAL EQUIPMENT CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 4, 2021

FOKUS Morphine Drug Cassette

Manufacturer:

GENIX TECHNOLOGY INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 13, 2021

FOKUS Reflex Hammer - Taylor Percussion Hammer 20 cm

Manufacturer:

CEATEC MEDIZINTECHNIK GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 16, 2020

AIMTB Blood Stimulation Tubes

Manufacturer:

GUANGZHOU LEIDE BIOSCIENCES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 28, 2020

AIMTB Assay Interferon Gamma Assay

Manufacturer:

GUANGZHOU LEIDE BIOSCIENCES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2020

ARTRON One-Step Methylenedioxymethamphetamine (MDMA) Urine Test

Manufacturer:

ARTRON LABORATORIES INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 10, 2020

ARTRON One-Step Tetrahydrocannabinol (THC) Urine Test

Manufacturer:

ARTRON LABORATORIES INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 3, 2020

ARTRON One-Step Benzodiazepine (BZO) Urine Test

Manufacturer:

ARTRON LABORATORIES INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 2, 2020

ARTRON One-Step Methamphetamine (MET) Urine Test

Manufacturer:

ARTRON LABORATORIES INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 2, 2020

ARTRON One-Step Barbiturates (BAR) Urine Test

Manufacturer:

ARTRON LABORATORIES INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 2, 2020

ARTRON One-Step Morphine (MOR) Urine Test

Manufacturer:

ARTRON LABORATORIES INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 2, 2020

ARTRON One-Step Cocaine (COC) Urine Test

Manufacturer:

ARTRON LABORATORIES INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 2, 2020

ARTRON One-Step Amphetamine (AMP) Urine Test

Manufacturer:

ARTRON LABORATORIES INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 26, 2020

FOKUS 5 in 1 Panel DOA Cassette (Amphetamine, Benzodiazepine, Marijuana/ THC, Methamphetamine, Morphine)

Manufacturer:

PULSE SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 10, 2020

FOKUS Multi Drug Dip Card 6 in 1 (AMP/ BZD/ COC/ THC/M-AMP/OPI)

Manufacturer:

ARTRON LABORATORIES INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 28, 2019

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

Last updated: December 2025