Manufacturer profileROCHE MOLECULAR SYSTEMS
IndonesiaUnited States8 products registered
VerifiedKemenkes (Ministry of Health) · official registry
8
Total Products
8
Product Names
2
Product Classes
3
Risk Classes
Regulatory footprint
Search ROCHE MOLECULAR SYSTEMS across other regulatory registries
Thailand
European Union
Colombia
South Korea
Canada
EcuadorRisk classification breakdown
Distribution of products across risk classes
Kelas Resiko : B225.0% of total
Kelas Resiko : C562.5% of total
Kelas Resiko : D112.5% of total
Product class portfolio
Products organized by product class
Kelas : 2
COBAS SARS-CoV-2 Nucleic acid test for use on the cobas Liat System, COBAS PIK3CA Mutation Test (PIK3CA), COBAS MTB Positive Control Kit for use on the cobas 6800/8800 Systems, COBAS MTB Nucleic acid test for use on the cobas 6800/8800 Systems, cobas SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas Liat Systems ... and 2 more products in this class
7 Products
Kelas : 3
COBAS HBV
1 Products
Recent registrations (8 most recent)
Most recently registered products with Ministry of Health
COBAS SARS-CoV-2 Nucleic acid test for use on the cobas Liat System
Sep 8, 2024
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PIK3CA Mutation Test (PIK3CA)
Aug 30, 2024
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS MTB Positive Control Kit for use on the cobas 6800/8800 Systems
Feb 17, 2023
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS MTB Nucleic acid test for use on the cobas 6800/8800 Systems
Feb 15, 2023
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
cobas SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas Liat Systems
Aug 9, 2022
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS HBV
Jun 27, 2022
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS HPV Qualitative nucleic acid test for use on the cobas 6800/8800 systems
Nov 25, 2021
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
cobas HPV Positive Control for use on the cobas 6800/8800 Systems
Nov 23, 2021
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
About this profile
ROCHE MOLECULAR SYSTEMS from United States is a medical device manufacturer with 8 registered products in the Indonesia Ministry of Health database through Pure Global AI's free platform. The company produces 8 unique product types across 2 product classes.
This page provides comprehensive manufacturer intelligence including complete product portfolio, risk class distribution, and product class analysis. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify manufacturers, analyze portfolios, and discover partnership opportunities efficiently.