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Human Papillomavirus Genotyping Kit for 23 Types (PCR-Reverse Dot Blot)

by Yaneng BIOscience (Shenzhen) Co., Ltd. 3 variants

Ref 212601

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06955931305011 Basic UDI-DI Date3 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
212601
Primary DI / UDI-DI
06955931305011, 06955931305035, 06955931305042
Basic UDI-DI
B-06955931305011, B-06955931305035, B-06955931305042
EMDN Code
W0105041004 Full genotyping high-risk + low-risk hpv - na reagents
Device Class
Class IVD General
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000013666
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

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