AFIAS Cyfra 21-1 - Indonesia BPOM Medical Device Registration
AFIAS Cyfra 21-1 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306420240. 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
Feb 05, 2029
Product Type
Tumor Antigen Immunologic Test System
Tumor-associated antigen immunological test system.
Invitro Diagnostics
AFIAS NT-proBNP
AFIAS D-Dimer Neo
AFIAS PSA
AFIAS CRP
AFIAS TSH
AFIAS PCT X
BODITECH RF IgM Control
BODITECH TSH Plus Control
AFIAS Vitamin D Neo
BODITECH Calprotectin Control
AFIAS CRP
BODITECH MED INC.,
AFIAS PSA
BODITECH MED INC.,
AFIAS Ferritin
BODITECH WITH INC.
AFIAS NT-proBNP
BODITECH MED INC.,
AFIAS Tn-I Plus
BODITECH WITH INC.
AFIAS D-Dimer Neo
BODITECH MED INC.,
AFIAS TSH
BODITECH MED INC.,
AFIAS PCT X
BODITECH MED INC.,
BODITECH RF IgM Control
BODITECH MED INC.,
BODITECH TSH Plus Control
BODITECH MED INC.,