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TRUPCR® TORCH Panel Kit

by 3B BlackBio Dx Limited India EUDAMED

Ref 3B1271/C EMDN W0105070302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number89080153043B1271L7 Basic UDI-DIDate31 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
3B1271/C
Primary DI / UDI-DI
08908015304958
Basic UDI-DI
89080153043B1271L7
EMDN Code
W0105070302 Other virus combinations - multiplex na reagents
Device Class
Class C
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

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See all devices from 3B BlackBio Dx Limited →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 646f6e26-2ec7-4e55-a105-0390b1f2183c 61 fields · synced 24 Oct 2026