AFIAS PCT X - Indonesia BPOM Medical Device Registration
AFIAS PCT X is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303420213. The device is manufactured by BODITECH MED INC., from Korea, and is classified as Risk Class Kelas Resiko : B. 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 06, 2025
Expiry Date
Feb 05, 2029
Product Type
Serological Reagents
Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis
Invitro Diagnostics
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AFIAS CRP
AFIAS D-Dimer Neo
AFIAS NT-proBNP
AFIAS TSH
BODITECH RF IgM Control
AFIAS Vitamin D Neo
BODITECH TSH Plus Control
BODITECH Calprotectin Control
AFIAS NT-proBNP
BODITECH MED INC.,
AFIAS PSA
BODITECH MED INC.,
AFIAS D-Dimer Neo
BODITECH MED INC.,
AFIAS Ferritin
BODITECH WITH INC.
AFIAS Tn-I Plus
BODITECH WITH INC.
AFIAS Cyfra 21-1
BODITECH MED INC.,
AFIAS CRP
BODITECH MED INC.,
AFIAS TSH
BODITECH MED INC.,
BODITECH RF IgM Control
BODITECH MED INC.,
AFIAS Vitamin D Neo
BODITECH MED INC.,