← Back to catalogue

TRUPCR® Influenza A/B & RSV with SARS-CoV-2 RT qPCR Kit

EUDAMED

Class C (EU MDR)

Ref 3B012/C

by 3B BlackBio Dx Limited

Identity

Trade Name
TRUPCR® Influenza A/B & RSV with SARS-CoV-2 RT qPCR Kit EUDAMED
Device Name
TRUPCR® Influenza A/B & RSV with SARS-CoV-2 RT qPCR Kit EUDAMED
Model / Reference
3B012/C EUDAMED

Identifiers

Primary DI / UDI-DI
08908015304781 EUDAMED
Basic UDI-DI
89080153043B012MQ EUDAMED
EMDN Code
W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS EUDAMED

Classification

Device Class
Class C EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

TRUPCR® Influenza A/B & RSV with SARS-CoV-2 RT qPCR Kit by 3B BlackBio Dx Limited — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
3B BlackBio Dx Limited
EUDAMED SRN
IN-MF-000023698
Authorised Representative
Wellkang Ltd XI-AR-000001836

Sources (1)

  • EUDAMED ecc2fdb0-ecce-48de-991f-1824a81e7154 61 fields · synced Jun 18, 2026