Skip to content

Actilite

by Brightwake Limited 6 variants

Ref CR4366

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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/MDD NumberB-05060031479881 Basic UDI-DI 05060031479881UDI-DIDate5 Feb 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
CR4366
Primary DI / UDI-DI
05060031479881
Basic UDI-DI
B-05060031479881
EMDN Code
M040499 Dressings for wounds, sores and ulcerations - other
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

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

Related devices

Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial

Other devices from Brightwake Limited

See all devices from Brightwake Limited →

Properties

  • Sterile

Other properties (10)

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