HEMOLYZER 5 NG Hematology Analyzer (Open Mode) - Indonesia BPOM Medical Device Registration

HEMOLYZER 5 NG Hematology Analyzer (Open Mode) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20205917120. The device is manufactured by NORMA INSTRUMENTS ZRT from Hungary, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. BRIDGE TWO.

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BPOM Registered

Risk Class Kelas Resiko : B

HEMOLYZER 5 NG Hematology Analyzer (Open Mode)

Analysis ID: AKL 20205917120

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

NORMA INSTRUMENTS ZRT

Country of Origin

Hungary

Authorized Representative

AR Address

Petojo Melintang No. 17 Kel. Petojo Selatan, Kec. Gambir Jakarta Pusat

Registration Date

Nov 01, 2019

Expiry Date

Feb 04, 2024

Product Type

Automatic and Semi-Automatic Hematology Equipment

Automated differential cell counter.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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Products from the same manufacturer (3 products)

NormaCont3+ KIT K1 (2L, 2N, 2H)

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Kelas Resiko : A