BALIO OX580 Auto Hematology Analyzer and Accesories - Indonesia BPOM Medical Device Registration

BALIO OX580 Auto Hematology Analyzer and Accesories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20205024473. The device is manufactured by SHENZHEN DYMIND BIOTECHNOLOGY CO.,LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. MAIN MEDICAL CHAKRA.

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BPOM Registered

Risk Class Kelas Resiko : B

BALIO OX580 Auto Hematology Analyzer and Accesories

Analysis ID: AKL 20205024473

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

SHENZHEN DYMIND BIOTECHNOLOGY CO.,LTD

Country of Origin

China

Authorized Representative

PT. MAIN MEDICAL CHAKRA

AR Address

FORESTA BUSINESS LOFT 6 No. 10, Jl. Raya Boulevard Utara BSD City, Desa/Kelurahan Lengkong Kulon

Registration Date

Mar 05, 2024

Expiry Date

Dec 28, 2028

Product Type

Automatic and Semi-Automatic Hematology Equipment

Automated cell counter.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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