AFIAS PSA - Indonesia BPOM Medical Device Registration
AFIAS PSA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306420027. The device is manufactured by BODITECH MED INC., from Korea, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. BODITECH MED INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
BODITECH MED INC.,Country of Origin
Korea
Authorized Representative
PT. BODITECH MED INDONESIAAR Address
Ruko Alam Sutera, Jalur Sutera Kavling 25 B-C No.1
Registration Date
Feb 10, 2025
Expiry Date
Oct 25, 2028
Product Type
Tumor Antigen Immunologic Test System
Tumor-associated antigen immunological test system.
Invitro Diagnostics
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