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Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR)

by Sanway Gene Tech. Inc. EUDAMED

Active European Union

Ref C004E

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974960210004 Basic UDI-DIDate20 Jan 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR)
Model / Reference
C004E
Primary DI / UDI-DI
06974960210004
Basic UDI-DI
B-06974960210004
EMDN Code
W0105070301 Hbv / hcv / HIV combination - multiplex na reagents
Device Class
Class IVD Annex II List A
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000037912
Authorised representative
Obelis s.a. BE-AR-000000106

Properties

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No