FOKUS Direct Bilirubin (D- Bil/VOX) - Indonesia BPOM Medical Device Registration
FOKUS Direct Bilirubin (D- Bil/VOX) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101323383. The device is manufactured by SHENZHEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FOCUS DIAGNOSTIC INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
SHENZHEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD.Country of Origin
China
Authorized Representative
PT. FOCUS DIAGNOSTIC INDONESIAAR Address
Jl. Jatipadang Raya No.9A, RT.6/RW.4, Kelurahan Jatipadang, Kecamatan Pasar Minggu, Kota Jakarta Selatan, DKI Jakarta 12540
Registration Date
Jun 30, 2023
Expiry Date
Jun 28, 2026
Product Type
Clinical Chemistry Test System
Bilirubin (total or direct) test system (kit & cair)
Invitro Diagnostics
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