WONDFO PCT (CLIA) - Indonesia BPOM Medical Device Registration
WONDFO PCT (CLIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303420632. 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 PT. 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
PT. ZOE PELITA NUSANTARAAR Address
JALAN CIKINI II NO 8 B
Registration Date
Dec 02, 2024
Expiry Date
Jul 29, 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
WONDFO CA19-9 (CLIA)
WONDFO IgE (CLIA)
WONDFO CA125 (CLIA)
WONDFO ฮฒ-HCG (CLIA)
WONDFO AFP (CLIA)
WONDFO Free Thyroxine (CLIA)
WONDFO Folate (CLIA)
WONDFO LH (CLIA)
WONDFO Free Triiodothyronine (CLIA)
WONDFO hs cTnI (CLIA)
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WONDFO IgE (CLIA)
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