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HELENA Actalyke MINI II Analyzer 5755 and Accessories - Indonesia BPOM Medical Device Registration

HELENA Actalyke MINI II Analyzer 5755 and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207615382. The device is manufactured by HELENA LABORATORIES. from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is ABADINUSA USAHASEMESTA.

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BPOM Registered
Risk Class Kelas Resiko : C
HELENA Actalyke MINI II Analyzer 5755 and Accessories
Analysis ID: AKL 20207615382

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

ABADINUSA USAHASEMESTA

AR Address

Jalan Raden Saleh No. 45 G

Registration Date

Dec 08, 2023

Expiry Date

Dec 31, 2025

Product Type

Haematology Package and Kit

Activated whole blood clotting time tests.

Invitro Diagnostics

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