SHARPENS CA19-9 - Indonesia BPOM Medical Device Registration
SHARPENS CA19-9 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306420221. 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 BODITECH MED INDONESIA.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
AFIAS CA19-9
Risk Classification
Product Class
Kelas : 2
Manufacturer
BODITECH MED INC.,Country of Origin
Korea
Authorized Representative
BODITECH MED INDONESIAAR Address
Ruko Alam Sutera, Jalur Sutera Kavling 25 B-C No.1
Registration Date
Nov 09, 2024
Expiry Date
Feb 05, 2029
Product Type
Tumor Antigen Immunologic Test System
Tumor-associated antigen immunological test system.
Invitro Diagnostics
AFIAS CRP
AFIAS PSA
AFIAS D-Dimer Neo
AFIAS Cyfra 21-1
AFIAS NT-proBNP
AFIAS TSH
AFIAS PCT X
BODITECH RF IgM Control
BODITECH TSH Plus Control
AFIAS Vitamin D Neo
BODITECH D-Dimer Control
BODITECH MED INC.,
AFIAS TSH PLUS
BODITECH MED INC.,
BODITECH Vitamin D Control
BODITECH MED INC.,
AFIAS Total IgE
BODITECH MED INC.,
Boditech Ferritin Control
BODITECH MED INC.,
BODITECH Hormone Control
BODITECH MED INC.,
AFIAS ST2
BODITECH MED INC.,
BODITECH HbA1c Control
BODITECH MED INC.,
BODITECH Tumor Marker Control
BODITECH MED INC.,
BODITECH CRP Control
BODITECH WITH INC