API NH - Indonesia BPOM Medical Device Registration

API NH is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20302802107. The device is manufactured by BIOMERIEUX SA. (LA BALME LES GROTTES) from France, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. ENSEVAL MEDIKA PRIMA.

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BPOM Registered

Risk Class Kelas Resiko : C

API NH

Analysis ID: AKL 20302802107

Risk Classification

Kelas Resiko : C

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 23, 2024

Expiry Date

Dec 31, 2028

Product Type

Microbiology Equipment

Culture medium for pathogenic Neisseria spp.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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