Skip to content

Hart Biologicals

by Hart Biologicals Ltd. United Kingdom EUDAMED

Ref HB-5615-FG EMDN W0103020217

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-HB-5615-FGXB Basic UDI-DIDate25 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Ristocetin MEA
Model / Reference
HB-5615-FG
Primary DI / UDI-DI
D-HB-5615-FGXB
Basic UDI-DI
B-HB-5615-FGXB
EMDN Code
W0103020217 Coagulation factor von willebrand activity / ristocetin cofactor activity (rco)
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
GB-MF-000029121
Authorised representative
Amstermed UK Ltd XI-AR-000023135

Other devices from Hart Biologicals Ltd.

See all devices from Hart Biologicals Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 51eb58de-84c4-4ecd-b079-34f85a528c80 61 fields · synced 24 Oct 2026