API 20 A - Indonesia BPOM Medical Device Registration

API 20 A is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20302024451. The device is manufactured by BIOMERIEUX SA. (LA BALME LES GROTTES) from France, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ENSEVAL MEDIKA PRIMA.

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BPOM Registered

Risk Class Kelas Resiko : B

API 20 A

Analysis ID: AKL 20302024451

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

BIOMERIEUX SA. (LA BALME LES GROTTES)

Country of Origin

France

Authorized Representative

PT. ENSEVAL MEDIKA PRIMA

AR Address

JL. PULO LENTUT NO.12, LT.1 UNIT 1C & LT.2 UNIT 2A, KAWASAN INDUSTRI PULOGADUNG

Registration Date

Sep 27, 2024

Expiry Date

Dec 31, 2028

Product Type

Microbiology Equipment

Microorganism differentiation and identification device.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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