COBAS ACET2 ONLINE TDM Acetaminophen Gen.2 COBAS INTEGRA/ COBAS c sytems - Indonesia BPOM Medical Device Registration
COBAS ACET2 ONLINE TDM Acetaminophen Gen.2 COBAS INTEGRA/ COBAS c sytems is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20103611307. The device is manufactured by ROCHE DIAGNOSTICS GMBH. from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ROCHE INDONESIA.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
COBAS ACET2 ONLINE TDM Acetaminophen Gen.2 COBAS INTEGRA/ cobas c sytems
Risk Classification
Product Class
Kelas : 2
Manufacturer
ROCHE DIAGNOSTICS GMBH.Country of Origin
Germany
Authorized Representative
PT. ROCHE INDONESIAAR Address
Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi
Registration Date
Aug 12, 2024
Expiry Date
Jun 18, 2029
Product Type
Clinical Toxicology Test System
Acetaminophen test system (card)
Invitro Diagnostics
COBAS PreciControl CMV IgG Avidity Elecsys and cobas e analyzers
COBAS CREP2 Creatinine Plus ver.2 COBAS INTEGRA / cobas c systems
Elecsys Anti-SARS-CoV-2 cobas e analyzers
COAGUCHEK PT Test
COBAS Elecsys CA 15-3 ll Elecsys and cobas e analyzer
COBAS NSE Elecsys and Cobas e Analyzer
ISE Reference Electrolyte Roche / Hitachi cobas c
COBAS Insulin CalSet Elecsys and cobas e analyzers
COBAS CA 19-9 Calset Elecsys and cobas e analyzers
COBAS Elecsys Anti-HAV IgM Elecsys and cobas e analyzers
COBAS PreciControl CMV IgG Avidity Elecsys and cobas e analyzers
ROCHE DIAGNOSTICS GMBH.
COBAS MPXV
ROCHE MOLECULAR SYSTEMS, INC.
COBAS CREP2 Creatinine Plus ver.2 COBAS INTEGRA / cobas c systems
ROCHE DIAGNOSTICS GMBH.
COAGUCHEK PT Test
ROCHE DIAGNOSTICS GMBH.
COBAS S2 Fluid Pack
ROCHE DIAGNOSTICS INTERNATIONAL, LTD.
ROCHE Cardiac POC Troponin T 2-Level Control
ROCHE DIAGNOSTICS GMBH
COBAS Elecsys CA 15-3 ll Elecsys and cobas e analyzer
ROCHE DIAGNOSTICS GMBH.
COBAS u 601 Urine Analyzer and Accessories
77 ELECTRONICS INSTRUMENT INDUSTRY LTD.
ISE Reference Electrolyte Roche / Hitachi cobas c
ROCHE DIAGNOSTICS GMBH.
COBAS Insulin CalSet Elecsys and cobas e analyzers
ROCHE DIAGNOSTICS GMBH.