WONDFO β-HCG (CLIA) - Indonesia BPOM Medical Device Registration
WONDFO β-HCG (CLIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101421734. The device is manufactured by SHENZEN TISENC MEDICAL DEVICES CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is ZOE PELITA NUSANTARA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
SHENZEN TISENC MEDICAL DEVICES CO., LTD.Country of Origin
China
Authorized Representative
ZOE PELITA NUSANTARAAR Address
JALAN CIKINI II NO 8 B
Registration Date
Sep 04, 2024
Expiry Date
Aug 01, 2028
Product Type
Clinical Chemistry Test System
Human chorionic gonadotropin (HCG) test system (kit & cair)
Invitro Diagnostics
WONDFO PCT (CLIA)
WONDFO CA19-9 (CLIA)
WONDFO IgE (CLIA)
WONDFO CA125 (CLIA)
WONDFO AFP (CLIA)
WONDFO Folate (CLIA)
WONDFO LH (CLIA)
WONDFO Free Thyroxine (CLIA)
WONDFO Free Triiodothyronine (CLIA)
WONDFO hs cTnI (CLIA)
WONDFO CA19-9 (CLIA)
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