ERBA ALT/GPT 330 - Indonesia BPOM Medical Device Registration
ERBA ALT/GPT 330 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101122255. The device is manufactured by ERBA LACHEMA S.R.O. from Czech Republic, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ELBA LAB MEDIKA.
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
ERBA LACHEMA S.R.O.Country of Origin
Czech Republic
Authorized Representative
PT. ELBA LAB MEDIKAAR Address
GRAHA BUMI INDAH LANTAI II ROOM 2005, JL. RAYA KALIMALANG KAV. AGRARIA NO. 8-0 RT/RW 002/016 KEL. DUREN SAWIT KEC. DUREN SAWIT JAKARTA TIMUR
Registration Date
Apr 19, 2021
Expiry Date
Sep 06, 2024
Product Type
Clinical Chemistry Test System
Alanine amino transferase (ALT/SGPT) test system (kit & cair)
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