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BIOMAXIMA Bilirubin Direct - Indonesia BPOM Medical Device Registration

BIOMAXIMA Bilirubin Direct is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101910311. The device is manufactured by BIOMAXIMA S.A. from Poland, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is WHIRA PITOE JOINT VENTURE.

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Risk Class Kelas Resiko : B
BIOMAXIMA Bilirubin Direct
Analysis ID: AKL 20101910311

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

BIOMAXIMA S.A.

Country of Origin

Poland

Authorized Representative

WHIRA PITOE JOINT VENTURE

AR Address

Ruko Buaran Persada NO. 10, Jl. Jend. R.S. Soekanto RT.008 RW.006

Registration Date

Oct 23, 2024

Expiry Date

Aug 08, 2029

Product Type

Clinical Chemistry Test System

Bilirubin (total or direct) test system (kit & cair)

Invitro Diagnostics

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