WONDFO IgE (CLIA) - Indonesia BPOM Medical Device Registration
WONDFO IgE (CLIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305420589. 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
Nov 22, 2024
Expiry Date
Aug 01, 2028
Product Type
Immunological Test System
Immunoglobulins A, G, M, D, and E immunological test system.
Invitro Diagnostics
WONDFO PCT (CLIA)
WONDFO CA19-9 (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)
HEALGEN Human Papillomavirus 14 Types Detection Kit(Fluorescence PCR)
HEALGEN SCIENTIFIC LIMITED LIABILITY COMPANY.
FURUNO Lipase
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FURUNO LDH-L fluid (5+1)
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FURUNO Iron TIBC
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FURUNO Wash Solution 1
CENTRONIC GMBH
FURUNO Wash Solution 2
CENTRONIC GMBH
WONDFO PCT (CLIA)
SHENZEN TISENC MEDICAL DEVICES CO., LTD.
FURUNO Centronorm
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FURUNO Saline Diluent
CENTRONIC GMBH
FURUNO Glucose HK Fluid 5+1
CENTRONIC GMBH

