HOTGEN Total Prostate Specific Antigen Test (t-PSA-CLIA) - Indonesia BPOM Medical Device Registration
HOTGEN Total Prostate Specific Antigen Test (t-PSA-CLIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306520019. The device is manufactured by BEIJING HOTGEN BIOTECH CO. LTD from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. ZEFINDO DARYA MEGATAMA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
BEIJING HOTGEN BIOTECH CO. LTDCountry of Origin
China
Authorized Representative
PT. ZEFINDO DARYA MEGATAMAAR Address
Jl. Jemursari No 329-331 B, Kode Pos 60239, Desa/Kelurahan Sidosermo, Kec. Wonocolo, Kota Surabaya, Prov. Jawa Timur
Registration Date
Feb 01, 2025
Expiry Date
Nov 28, 2028
Product Type
Tumor Antigen Immunologic Test System
Tumor-associated antigen immunological test system.
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