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TRUPCR® HPV HR with 16 & 18 Differentiation Kit

by 3B BlackBio Dx Limited

Ref 3B1439C

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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/IVDR Number89080153043B1439CM4 Basic UDI-DI 08908015304224UDI-DIDate18 Nov 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
3B1439C
Primary DI / UDI-DI
08908015304224
Basic UDI-DI
89080153043B1439CM4
Direct Marketing DI
08908015304224
EMDN Code
W01060299 Tests for acquired genetic or chromosomal alterations - other
Device Class
Class C
EU market of registration
France

Manufacturer details

EUDAMED SRN
IN-MF-000023698
Authorised representative
Wellkang Ltd XI-AR-000001836

From the manufacturer

Manufacturer's product page: TRUPCR ® IDH1/2 Detection & Differentiation Kit

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See all devices from 3B BlackBio Dx Limited →

Properties

  • Reagent
  • Professional Testing
  • New Device

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