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Eclypse Contour CR4398

by Brightwake Limited

Ref CR4398

Eclypse Contour CR4398 is a device classified as Class IIb in the EU and Class I in the US made by Brightwake Limited, registered in EUDAMED on 9 Sep 2026 (Basic UDI-DI B-05060031479676) and listed in FDA GUDID since 27 Jul 2023 (UDI-DI 05060031479676), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05060031479676 Basic UDI-DI 05060031479676UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060031479676 UDI-DI Date27 Jul 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05060031479676 registered 9 Sep 2026 Active
  • FDA GUDID UDI-DI 05060031479676 listed 27 Jul 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05060031479676
  2. Registered EUDAMED B-05060031479676

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  • Withdrawn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

Trade name
Eclypse Contour
Generic name
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Model / reference
CR4398
Primary DI / UDI-DI
05060031479676
Basic UDI-DI
B-05060031479676
FDA product code
NAC
EMDN code
M040204 Non-adherent absorbent dressings
GMDN term
Exudate-absorbent dressing, hydrophilic-gel, 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 — 51 Centimeter
Width — 30 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.

Related devices

Category: Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

Similar devices in this category

Other devices filed under NON-ADHERENT ABSORBENT DRESSINGS.

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)