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Silflex

by Brightwake Limited 5 variants

Ref CR4006

Silflex (CR4006) is a device classified as Class IIb in the EU and Class I in the US made by Brightwake Limited, registered in EUDAMED on 26 Feb 2025 (Basic UDI-DI B-05060031473865) and listed in FDA GUDID since 27 Jul 2023 (UDI-DI 05060031473865), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05060031473865 Basic UDI-DI 05060031473865UDI-DIDate26 Feb 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05060031473865 UDI-DI Date27 Jul 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05060031473865 registered 26 Feb 2025 Active
  • FDA GUDID UDI-DI 05060031473865 listed 27 Jul 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05060031473865
  2. Registered EUDAMED B-05060031473865

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Wound-nonadherent dressing, permeable, non-antimicrobial
Model / reference
CR4006
Primary DI / UDI-DI
05060031473865
Basic UDI-DI
B-05060031473865
FDA product code
NAD
EMDN code
M04040701 Silicone dressings, non-combined
GMDN term
Wound-nonadherent dressing, permeable, non-antimicrobial
Device class
Class IIb EUDAMED
Class I GUDID
Regulation number
878.4020
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Length — 60 Centimeter
Width — 35 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class I

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

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

Similar devices in this category

Other devices filed under SILICONE DRESSINGS, NON-COMBINED.

Other devices from Brightwake Limited

See all devices from Brightwake Limited →

Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)