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14 High-risk HPV with 16/18 Genotyping Real-time PCR Kit

by Chaozhou Hybribio Biochemistry Ltd.

Ref HBRT-H14Model 48 Tests/Kit, 6 Tests/Kit

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06942221703183 Basic UDI-DI Date27 May 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  • Withdrawn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

Device Name
14 High-risk HPV with 16/18 Genotyping Real-time PCR Kit
Model / Reference
48 Tests/Kit, HBRT-H14, 6 Tests/Kit
Primary DI / UDI-DI
06942221703183, 06942221701608
Basic UDI-DI
B-06942221703183, B-06942221701608
EMDN Code
W0105041003 Partial genotyping high-risk hpv - na reagents
Device Class
Class IVD General
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000023818
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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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