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PT. BINTANG MONO INDONESIA

Authorized Representative in Indonesia

Taman Tekno BSD Sektor XI Blok J 03 No.25 RT 019 RW 005
143 Products Represented
14 Manufacturers
Total Products
143
Manufacturers
14
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
2 products
1.4%
Kelas Resiko : B
85 products
59.4%
Kelas Resiko : C
42 products
29.4%
Kelas Resiko : D
14 products
9.8%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (143)
Complete portfolio registered with BPOM

MONOTES Micro Blood Collection Tubes EDTA K3 PET Tube

Manufacturer:

JIANGSU RONGYE TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2024

MONOTES Sterile Lancet Twisted Type

Manufacturer:

JIANGSU RONGYE TECHNOLOGY CO.,LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 2, 2024

LYSUN BHM-102 Hemoglobin Analysis Meter

Manufacturer:

HANGZHOU LYSUN BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2024

MONOTES Vacuum Tube EDTA K3 Glass Tube

Manufacturer:

JIANGSU RONGYE TECHNOLOGY CO, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2024

MONOTES Vacuum Tube Glucose Glass Tube

Manufacturer:

JIANGSU RONGYE TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2024

MONOTES FIA Analyzer BIOT-YG-I and Accesories

Manufacturer:

XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 27, 2024

MONOTES Vacuum Tube Glucose PET Tube

Manufacturer:

JIANGSU RONGYE TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

MONOTES Vacuum Tube ESR Sodium Sitrate/4NC PET Tube

Manufacturer:

JIANGSU RONGYE TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

MONOTES Vacuum Tube Glass Plain (No Additive)

Manufacturer:

JIANGSU RONGYE TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

MONOTES Vacuum Tube EDTA K3 PET Tube

Manufacturer:

JIANGSU RONGYE TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 22, 2024

HEALGEN Urine Alcohol Test Strip

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2024

MONOTES Vacuum Tube PT (Sodium Citrate/9NC) PET Tube

Manufacturer:

JIANGSU RONGYE TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2024

HEALGEN K2 (JWH Series) Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

HEALGEN Multi Drug Of Abuse Multi 7 (MET 500, COC 300, MOP (Opiat) 300, AMP 1000, BZO 300, THC 50, Carisoprodol (SOMA) 1000)

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 26, 2024

HEALGEN Multi Drug of Abuse Multi 7 (MET 1000 , COC 300, MOP 300, AMP 1000, BZO 300, THC 50, K2 50 )

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 26, 2024

HEALGEN Multi Drug of Abuse 6 in 1 Cup Test (AMP1000ng,THC50ng, MOP300ng, COC300ng, MET1000ng, BZO300ng)

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 26, 2024

HEALGEN Multi Drug of Abuse 7 in 1 Cup Test (MET 500, COC 300, MOP (Opiat) 300, AMP 1000, BZO 300, THC 50, Carisoprodol (SOMA) 1000)

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 26, 2024

HEALGEN Multi Drug of Abuse 6 in 1 Saliva Test Cup (THC12, COC20, MOP15, MET50, AMP50, BZO10)

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 26, 2024

HEALGEN MDMA Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 12, 2024

HEALGEN Multi Drug of Abuse 7 in 1 Cup Test (AMP100ng, MOP300ng, THC50ng, COC300ng, MET1000ng, BZO300ng, K250ng)

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 11, 2024

HEALGEN HIV 1/2 Human Immunodefficiency Virus Rapid Test

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 11, 2024

HEALGEN MET Methamphetamines Test Cassete

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 8, 2024

HEALGEN URS-10 T Reagent Strips for Urinalysis Anti-VC Interverence Ability (Leukocytes, Nitrite, Urobilinogen, pH , Protein, Blood, Specific Gravity , Ketone, Bilirubin, Glucose)

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 8, 2024

HEALGEN Multi Drug of Abuse Multi 3 (MDMA 500ng, THC 50ng, AMP1000ng)

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 8, 2024

HEALGEN Multi Drug of Abuse Multi 4 (AMP1000, THC50, MOP300, MET1000)

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 8, 2024

HEALGEN Multi Drug of Abuse Multi 3 (MOP300,AMP1000,THC50)

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 7, 2024

HEALGEN TB Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 5, 2024

HEALGEN THC Test Strip

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2024

HEALGEN SyphilisTest Strip

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 5, 2024

HEALGEN Typhoid Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2024

HEALGEN THC Test Cassette One Step Rapid Test

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2024

HEALGEN Multi Drug of Abuse Multi 5 (MET1000, MOP300, AMP1000, BZO300, THC50)

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 5, 2024

HEALGEN URS-3T Reagent Strips for Urinalysis (Glucose, pH, Protein)

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 5, 2024

HEALGEN HCV Test Strip

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO.. LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 4, 2024

HEALGEN HCV Test Casssette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 4, 2024

HEALGEN Malaria (Pf/Pv) Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 3, 2024

HEALGEN Syphilis Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 3, 2024

HEALGEN Multi Drug of Abuse Multi 5 (AMP1000, THC50, MOP300, COC300, MET1000)

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 3, 2024

HEALGEN Multi Drug of Abuse Multi 6 (MDMA 500, THC 50, AMP 1000, MOP 300, COC 300, BZO 300)

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 3, 2024

HEALGEN Dengue NS 1 Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 3, 2024

HEALGEN HAV IgM Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 3, 2024

HEALGEN MOP Morphine Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2024

HEALGEN COC Test Casssette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2024

HEALGEN Dengue IgG/IgM One Step Rapid Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 26, 2024

HEALGEN BZO Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2024

HEALGEN DOA Multi Panel 6 in 1 (AMP1000, THC50, MOP300, COC300, MET1000, BZO300)

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 21, 2024

HEALGEN BAR Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2024

HEALGEN AMP Test Strip

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

MONO X Fluorescence Immunoassay Analyzer (Immunofluorescence Chromatography)

Manufacturer:

AEHEALTH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 29, 2024

MONO T4 (Total Thyroxine) Rapid Quantitative Test (Immunofluorescence Assay) and Accessories

Manufacturer:

AEHEALTH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 29, 2024

MONO FT4 (FREE Thyroxine) Rapid Quantitative Test (Immunofluorescence Assay) and Accessories

Manufacturer:

AEHEALTH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 27, 2024

MONO HbA1c (Glycated Hemoglobin) Rapid Quantitative Test (Immunofluorescence Assay) and Accessories

Manufacturer:

AEHEALTH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 27, 2024

MONO FT3 (FREE Triiodothyronine) Rapid Quantitative Test (Immunofluorescence Assay) and Accessories

Manufacturer:

AEHEALTH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 27, 2024

HEALGEN AMP Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2024

MONO MAU (Microalbumin) Rapid Quantitative Test (Immnunofluorescence Assay) and Aceessories

Manufacturer:

AEHEALTH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2024

MONO T3 (Total Triiodothyronine) Rapid Quantitative Test (Immunofluorescence Assay) and Accessories

Manufacturer:

AEHEALTH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2024

MONO TSH (Thyroid Stimulating Hormone) Rapid Quantitative Test (Immunofluorescence Assay) and Accessories

Manufacturer:

AEHEALTH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2024

MONO D-Dimer Rapid Quantitative Test (Immunofluorescence Assay) and Accessories

Manufacturer:

AEHEALTH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 14, 2024

ORIENT GENE HBsAb Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO, LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 22, 2024

SEJOY Blood Glucose Test Strip BS-602

Manufacturer:

HANGZHOU SEJOY ELECTRONICS & INSTRUMENTS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 27, 2024

ORIENT GENE HBsAg Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 14, 2024

ORIENT GENE Typhoid Test Cassette Rapid Diagnostic Test

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 1, 2024

ORIENT GENE THC Rapid Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 28, 2024

ORIENT GENE THC Test Strip

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 28, 2024

ORIENT GENE Syphilis Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 17, 2024

ORIENT GENE TB Rapid Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 17, 2024

ORIENT GENE Syphilis Test Strip

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 14, 2024

ORIENT GENE Multi Drugs of Abuse Multi 6 (MET, COC, MOP, AMP, BZO, THC)

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 13, 2024

HEALGEN HBsAg Test Strip

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 6, 2024

LYSUN Blood Lipid Test Strip (Dry Chemistry)

Manufacturer:

HANGZHOU LYSUN BIOTECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 31, 2024

ORIENT GENE HBsAb Test Strip

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 18, 2024

HEALGEN HBsAb One Step Rapid Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 18, 2024

HEALGEN HBsAg Test Casssette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 18, 2024

ORIENT GENE HBsAg Test Strip

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 18, 2024

ORIENT GENE Multi Drug Of Abuse Multi 3 (AMP500, MET500, THC50)

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 29, 2023

HEALGEN Multi Drug Of Abuse Multi 3 (AMP500, MET500, THC50)

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 29, 2023

HEMONART CompactOne 9 ACT Analyzer

Manufacturer:

HEMONART MEDICAL SYSTEMS INDUSTRY TRADE JOINT STOCK COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 22, 2023

ORIENT GENE HIV 1/2 One Step Rapid Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 19, 2023

ORIENT GENE Multi Drug of Abuse Multi 7 (AMP, MOP, THC, COC, MET, BZO, K2)

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 14, 2023

ORIENT GENE Multi Drug of Abuse Multi 3 (MOP,AMP,THC)

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 13, 2023

ORIENT GENE MET Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2023

ORIENT GENE MET Test Strip

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2023

ORIENT GENE MOP Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2023

ORIENT GENE MOP Test Strip

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2023

ORIENT GENE Multi Drugs of Abuse Multi 5 (MET, COC, MOP, AMP, THC)

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 13, 2023

ORIENT GENE Multi Drug Of Abuse Multi 7 (MET, COC, MOP (Opiat), AMP, BZO, THC, Carisoprodol (SOMA))

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 6, 2023

MONO HbA1c (Glycated Hemoglobin) Rapid Quantitative Test (Immunofluorescence Assay) and Accessories

Manufacturer:

AEHEALTH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 4, 2023

ORIENT GENE HCV Rapid Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 4, 2023

MONO X Fluorescence Immunoassay Analyzer (Immunofluorescence Chromatography)

Manufacturer:

AEHEALTH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 4, 2023

ORIENT GENE Malaria (Pf/Pv) Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 4, 2023

ORIENT GENE hCG Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2023

ORIENT GENE HAV Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2023

ORIENT GENE hCG Test Strip

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2023

ORIENT GENE Dengue NS1 Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 2, 2023

ORIENT GENE Dengue IgG/IgM Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 1, 2023

ORIENT GENE Bar Rapid Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2023

ORIENT GENE COC Test Strip

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2023

ORIENT GENE BZO Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 30, 2023

ORIENT GENE BZO Test Strip

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 30, 2023

ORIENT GENE COC Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 30, 2023

ORIENT GENE AMP Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 30, 2023

ORIENT GENE AMP Rapid Test Strip

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 30, 2023

HEALGEN Multi Drug of Abuse 10 in 1 Cup Test (AMP, MOP(OPI), MET, THC, COC, BZO, SOMA, PCP, MTD, MDMA)

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2023

MONOTES Vacuum Tube Glass ESR Sodium Citrate/4NC

Manufacturer:

JIANGSU RONGYE TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2023

MONOTES TSH (Thyroid Stimulating Hormone) Rapid Quantitative Test (Immunofluorescence Assay) and Accessories

Manufacturer:

XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 4, 2023

MONOTES HbA1c (Glycated Hemoglobin) Rapid Quantitative Test (Immunofluorescence Assay) and Accessories

Manufacturer:

XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 4, 2023

MONOTES T4 (Total Thyroxine) Rapid Quantitative Test (Immunofluorescence Assay) and Accessories

Manufacturer:

XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 4, 2023

MONOTES Vacuum Tube Procoagulation (Activator) Glass Tube

Manufacturer:

JIANGSU RONGYE TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2023

MONOTES Vacuum Tube Glass PT (Sodium Sitrate/9NC)

Manufacturer:

JIANGSU RONGYE TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 22, 2023

MONOTES Vacuum Tube Gel & Clot Activator PET Tube

Manufacturer:

JIANGSU RONGYE TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 22, 2023

MONOTES Vacuum Tube Gel & Clot Activator Glass

Manufacturer:

JIANGSU RONGYE TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 21, 2023

MONOTES Vacuum Tube Procoagulation (Activator) PET Tube

Manufacturer:

JIANGSU RONGYE TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 21, 2023

MONOTES D-Dimer Rapid Quantitative Test (Immunofluorescence Assay) and Accessories

Manufacturer:

XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 18, 2023

HEALGEN URS-11T Reagent Strips for Urinalysis (Glucose,Bilirubin,Ketone,Specific Gravity,Blood,pH,Protein,Urobilinogen,Nitrite,Leukocytes,Ascorbic Acid)

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 14, 2023

HEALGEN Fecal Occult Blood Rapid Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2023

MONO FT4 (FREE Thyroxine) Rapid Quantitative Test (Immunofluorescence Assay) and Accessories

Manufacturer:

AEHEALTH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 2, 2023

MONO FT3 (FREE Triiodothyronine) Rapid Quantitative Test (Immunofluorescence Assay) and Accessories

Manufacturer:

AEHEALTH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 1, 2023

MONO D-Dimer Rapid Quantitative Test (Immunofluorescence Assay) and Accessories

Manufacturer:

AEHEALTH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 26, 2023

MONO T3 (Total Triiodothyronine) Rapid Quantitative Test (Immunofluorescence Assay) and Accessories

Manufacturer:

AEHEALTH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 20, 2023

MONO T4 (Total Thyroxine) Rapid Quantitative Test (Immunofluorescence Assay) and Accessories

Manufacturer:

AEHEALTH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 18, 2023

MONO TSH (Thyroid Stimulating Hormone) Rapid Quantitative Test (Immunofluorescence Assay) and Accessories

Manufacturer:

AEHEALTH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 18, 2023

LYSUN BHS-101 Hemoglobin Test Strip

Manufacturer:

HANGZHOU LYSUN BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 23, 2023

MONOTES Vacuum Tube Gel & Clot Activator PET Tube

Manufacturer:

JIANGSU RONGYE TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2022

MONOTES Vacuum Tube Glucose Glass Tube

Manufacturer:

JIANGSU RONGYE TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 20, 2022

MONOTES Vacuum Tube Glass PT (Sodium Sitrate/9NC)

Manufacturer:

JIANGSU RONGYE TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2022

MONOTES Vacuum Tube Procoagulation (Activator) Glass Tube

Manufacturer:

JIANGSU RONGYE TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 19, 2022

MONOTES Vacuum Tube Procoagulation (Activator) PET Tube

Manufacturer:

JIANGSU RONGYE TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 19, 2022

MONOTES Vacuum Tube Glass ESR Sodium Citrate/4NC

Manufacturer:

JIANGSU RONGYE TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 19, 2022

MONOTES Vacuum Tube Gel & Clot Activator Glass

Manufacturer:

JIANGSU RONGYE TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 19, 2022

MONOTES BAR Rapid Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 29, 2022

MONOTES Typhoid Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2022

MONOTES Vacuum Tube EDTA K3 Glass Tube

Manufacturer:

JIANGSU RONGYE TECHNOLOGY CO, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

MONOTES Micro Blood Collection Tubes EDTA K3 PET Tube

Manufacturer:

JIANGSU RONGYE TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 9, 2022

MONOTES THC Test strips

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 28, 2022

MONOTES THC Test cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 28, 2022

MONOTES Dengue IgG/IgM Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 25, 2022

MONOTES Multi Drugs Abuse Multi 3 ( AMP, THC, MOP )

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 12, 2022

MONOTES Multi Drugs Abuse Multi 6 (AMP,MOP,THC,COC,MET,BZO)

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 8, 2022

MONOTES TB Test Cassette

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 23, 2021

HEALGEN COVID-19 IgG/IgM Rapid Test Cassette (whole blood/serum/plasma)

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2021

RONGYE Viral Transport Tube with Specimen Collection Swab (Inactivated Preservative Medium)

Manufacturer:

JIANGSU RONGYE TECHNOLOGY CO.,LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 1, 2021

HEALGEN HBsAb Rapid Test Strip

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 26, 2020

ORIENT GENE HCV Rapid Test Strip

Manufacturer:

ZHEJIANG ORIENT GENE BIOTECH CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 19, 2019

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

Last updated: December 2025