GEM PREMIER 4000 PAK Sensor and Reagent Cartridge (pH, pCO2, pO2, Na+, K+, Cl, Ca++, Glucose, Lactatete, HcT, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2) - Indonesia BPOM Medical Device Registration
GEM PREMIER 4000 PAK Sensor and Reagent Cartridge (pH, pCO2, pO2, Na+, K+, Cl, Ca++, Glucose, Lactatete, HcT, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101811357. The device is manufactured by INSTRUMENTATION LABORATORIES CO. from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is ENSEVAL MEDIKA PRIMA.
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
INSTRUMENTATION LABORATORIES CO.Country of Origin
United States
Authorized Representative
ENSEVAL MEDIKA PRIMAAR Address
JL. PULO LENTUT NO.12, LT.1 UNIT 1C & LT.2 UNIT 2A, KAWASAN INDUSTRI PULOGADUNG
Registration Date
May 28, 2021
Expiry Date
Oct 28, 2024
Product Type
Clinical Chemistry Test System
Multi parameter clinical chemistry test system
Invitro Diagnostics
HEMOSIL dRVVT Confirm
GEM CVP 1
GEM CVP 4
GEM CVP Multipak
GEM PREMIER 4000 PAK IQM Sensor dan Reagent Cartridge 14 parameter (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2)
GEM CVP 2 with CO-Ox
ELVASENSE Mini Safety Lancet
TIANJIN HUAHONG TECHNOLOGY CO., LTD.
VIDASยฎ IFNg QC PANEL (IFNg QC)
BIOMERIEUX S.A. (CHEMIN DE L'ORME)., FRANCE
ID Color Catalase ( ID - ASE )
BIOMERIEUX SA.
BIOMERIEUX Oxidase Reagent
REMEL
VITEK 2 AST-N425
BIOMERIEUX INC.
B.R.A.H.M.S PCT LIVES
BIOMERIEUX SA.
ELVASENSE Blood Glucose Test Strip
TAIDOC TECHNOLOGY CORPORATION
BIOMERIEUX Serum Free
BIOMERIEUX S.A.
Eppendorf Centrifuge 5425R
EPPENDORF SE, GERMANY
VIDAS HBs Ag Ultra Confirmation
BIOMERIEUX SA.

