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TRUPCR® HPV 16 & 18 Kit

EUDAMED

Class C (EU MDR)

Ref 3B1276/CRef 3B1276Ref 3B1277Ref 3B1439C

by 3B BlackBio Dx Limited

Identity

Trade Name
TRUPCR® HPV 16 & 18 Kit EUDAMED
TRUPCR® HPV HR with 16 & 18 Differentiation Kit EUDAMED
Device Name
TRUPCR® HPV 16 & 18 Kit EUDAMED
TRUPCR® HPV HR with 16 & 18 Differentiation Kit EUDAMED
Model / Reference
3B1276/C EUDAMED
3B1276 EUDAMED
3B1277 EUDAMED
3B1439C EUDAMED

Identifiers

Primary DI / UDI-DI
08908015304743 EUDAMED
08908015304750 EUDAMED
08908015304767 EUDAMED
08908015304224 EUDAMED
Basic UDI-DI
89080153043B1276LH EUDAMED
89080153043B1439CM4 EUDAMED
Direct Marketing DI
08908015304224 EUDAMED
EMDN Code
W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED

Classification

Device Class
Class C EUDAMED
Market of Registration
Germany EUDAMED
France 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

EUDAMEDEUDAMED

TRUPCR® HPV 16 & 18 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

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Manufacturer

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

Sources (4)

  • EUDAMED b98fde5b-85cb-4d31-8e97-a432b61f367f 61 fields · synced Jul 26, 2026
  • EUDAMED 8f1417e9-5e39-47fa-9429-e67a0924bba8 61 fields · synced May 16, 2026
  • EUDAMED 21900448-df62-4a88-97a4-65640c142602 61 fields · synced May 17, 2026
  • EUDAMED 6e7829c5-d1de-4a95-b7e9-e5e27c31bb5e 61 fields · synced May 19, 2026