VITEK 2 AST-N425 - Indonesia BPOM Medical Device Registration
VITEK 2 AST-N425 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20301420046. The device is manufactured by BIOMERIEUX INC. from United States, and is classified as Risk Class Kelas Resiko : B. 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
BIOMERIEUX INC.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
Sep 10, 2024
Expiry Date
Dec 31, 2028
Product Type
Diagnostic Equipment
Antimicrobial susceptibility test disc.
Invitro Diagnostics
DENSICHECK Plus Instrument for VITEK 2 System and Accessories
BACT/ALERT BPN
BACT/ALERT BPA
VITEK 2 NH
VITEK 2 YST
VITEK 2 ANC
BACT/ ALERT FN Plus
BACT/ALERT PF Plus
BACT/ALERT FA Plus
MB/ BACT Antibiotic Supplement Kit
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
B.R.A.H.M.S PCT LIVES
BIOMERIEUX SA.
BIOMERIEUX Serum Free
BIOMERIEUX S.A.
ELVASENSE Blood Glucose Test Strip
TAIDOC TECHNOLOGY CORPORATION
Eppendorf Centrifuge 5425R
EPPENDORF SE, GERMANY
VIDAS HBs Ag Ultra Confirmation
BIOMERIEUX SA.
Eppendorf Centrifuge 5425
EPPENDORF SE, GERMANY

