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Advazorb Border

by Brightwake Limited 10 variants

Ref CR4193

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05060031475623 Basic UDI-DI 05060031475623UDI-DIDate6 Feb 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05060031475623 UDI-DI Date27 Jul 2023ListedStatusListed GUDID: in commercial distribution

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

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  • Withdrawn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, absorbent, non-antimicrobial
Model / reference
CR4193
Primary DI / UDI-DI
05060031475623
Basic UDI-DI
B-05060031475623
FDA product code
NAC
EMDN code
M040499 Dressings for wounds, sores and ulcerations - other
GMDN term
Wound-nonadherent dressing, absorbent, non-antimicrobial
Device class
Class IIb EUDAMED
Class I GUDID
Regulation number
878.4018
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Length — 15 Centimeter
Width — 15 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class I

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

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date

Other properties (18)

  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Manufacturing date: No