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XWAFH33-20-EE1

by Welland Medical Ltd

Ref XWAFH33-20-EE1Model HydroFrame

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5024310A2KW Basic UDI-DI 05024310969784UDI-DIDate1 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
HydroFrame, XWAFH33-20-EE1
Primary DI / UDI-DI
05024310969784
Basic UDI-DI
5024310A2KW
EMDN Code
M04041503 Dressings in solutions, emulsions, gels, powders with synthetic components
Device Class
Class I
EU market of registration
Estonia

Manufacturer details

EUDAMED SRN
GB-MF-000033194
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Welland Medical Ltd

See all devices from Welland Medical Ltd →

Properties

  • Animal Tissues

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No