Accu-Chek Guide Link Kit - Indonesia BPOM Medical Device Registration
Accu-Chek Guide Link Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101023671. The device is manufactured by SANMINA CORPORATION from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is 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.
Risk Classification
Product Class
Kelas : 2
Manufacturer
SANMINA CORPORATIONCountry of Origin
United States
Authorized Representative
ROCHE INDONESIAAR Address
Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi
Registration Date
Jul 03, 2020
Expiry Date
Feb 22, 2024
Product Type
Clinical Chemistry Test System
Glucose test system (kit & cair)
Invitro Diagnostics
GENEXPERT DX System GX-XVI and Accesories
GENEXPERT Infinity 80 Systems
GENEXPERT DX System GX-IV and Accesories
GENEXPERT DX System GX-II and Accesories
GeneXpert Infinity 48s Systems
ACCU-CHEK Guide Set Wireless Blood Glucose Meter and Lancing Device
CODMAN Cerelink ICP Monitor
ACCU-CHEK Guide Wireless Blood Glucose Meter Only
ACCU-CHEK Performance Set
Elecsys Anti-SARS-CoV-2 cobas e analyzers
ROCHE DIAGNOSTICS GMBH.
PreciControl Maternal Care
ROCHE DIAGNOSTICS GMBH
COAGUCHEK aPTT Test
ROCHE DIAGNOSTICS GMBH.
ROCHE TROP T Sensitive, Troponin T
ROCHE DIAGNOSTICS GMBH.
COBAS BM - Lactate
ROCHE DIAGNOSTICS GMBH.
ultraView Universal Alkaline Phosphatase Red Detection Kit
VENTANA MEDICAL SYSTEMS, INC.
COBAS Buffer Negative Control Kit for use on the cobas 6800/8800 Systems
ROCHE MOLECULAR SYSTEMS INC.
COBAS omni Wash Reagent
ROCHE MOLECULAR SYSTEMS INC.
COBAS omni Lysis Reagent
ROCHE MOLECULAR SYSTEMS INC.
COBAS omni Specimen Diluent
ROCHE MOLECULAR SYSTEMS INC.