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TRUPCR® Flu Panel with RSV detection Kit

by 3B BlackBio Dx Limited 3 variants

Ref 3B222

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 29 Oct 2026. What this means

Regulatory status

as of registry sync 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number89080153043B221N3 Basic UDI-DI 08906213930047UDI-DIDate15 Jun 2026RegisteredStatusActive

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  • Withdrawn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
3B222
Primary DI / UDI-DI
08906213930047
Basic UDI-DI
89080153043B221N3
EMDN Code
W0105070304 Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex na reagents
Device Class
Class B
EU market of registration
Germany

Manufacturer details

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

From the manufacturer

Manufacturer's product page: ALL Panel

Other devices from 3B BlackBio Dx Limited

See all devices from 3B BlackBio Dx Limited →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

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