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Spinreact Bilirubin Direct - Indonesia BPOM Medical Device Registration

Spinreact Bilirubin Direct is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101421121. The device is manufactured by SPINREACT, S.AU from Spain, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SEIMITSU DIAGNOSTICS.

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BPOM Registered
Risk Class Kelas Resiko : B
Spinreact Bilirubin Direct
Analysis ID: AKL 20101421121

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

SPINREACT, S.AU

Country of Origin

Spain

Authorized Representative

PT. SEIMITSU DIAGNOSTICS

AR Address

Harton Tower 7th Floor, Jl. Boulevard Artha Gading, Kel. Kelapa Gading Barat, Kec. Kelapa Gading, Jakarta Utara.

Registration Date

Jun 10, 2024

Expiry Date

Dec 31, 2027

Product Type

Clinical Chemistry Test System

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

Invitro Diagnostics

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