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Thromboplastin L

by Helena Biosciences Europe United Kingdom EUDAMED

Ref 5265L

EMDN W0103020101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number505601300PTMR Basic UDI-DIDate25 Jun 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
5265L
Primary DI / UDI-DI
05056013016557
Basic UDI-DI
505601300PTMR
EMDN Code
W0103020101 Prothrombin time ( quick test )
Device Class
Class C
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000028365
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Helena Biosciences Europe

See all devices from Helena Biosciences Europe →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 4a509884-e8e5-47ab-b0d2-6fbc1c99ba8c 61 fields · synced 22 Oct 2026