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Sofshield Laryngectomy Protector

by Brightwake Limited 9 variants

Ref AS4063Model AS3669 - Large White

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506003147Sofshield9K Basic UDI-DI 05060031482881UDI-DIDate14 May 2024RegisteredStatusActive

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  • Withdrawn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
AS3669 - Large White, AS4063
Primary DI / UDI-DI
05060031482881
Basic UDI-DI
506003147Sofshield9K
EMDN Code
R01058099 Tracheostomy and laryngectomy cannulas - various accessories
Device Class
Class I
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000012039
Authorised representative
CS Life Sciences Europe Ltd IE-AR-000004113

Other devices from Brightwake Limited

See all devices from Brightwake Limited →

Properties

Other properties (13)

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