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Avelle 421552

by Convatec, Purchasing Department

Part of a family of 7 devices: see the family page

Ref 421552Model Avelle Dressings

Avelle 421552 is a device classified as Class IIb in the EU and Class II in the US made by Convatec, Purchasing Department, registered in EUDAMED on 10 Oct 2026 (Basic UDI-DI 768455AWC00033C), cleared under FDA 510(k) K180205 on 19 Oct 2018 and listed in FDA GUDID since 9 Sep 2022 (UDI-DI 00768455139255), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K180205

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number768455AWC00033C Basic UDI-DI 00768455139255UDI-DIDate10 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00768455139255 UDI-DI Date9 Sep 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK180205 Date19 Oct 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 768455AWC00033C registered 10 Oct 2026 Active
  • FDA 510(k) K180205 decided 19 Oct 2018 Active
  • FDA GUDID UDI-DI 00768455139255 listed 9 Sep 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K180205
  2. Listed FDA GUDID 00768455139255
  3. Registered EUDAMED 768455AWC00033C

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Avelle NPWT Dressing EUDAMED
Avelle GUDID
Generic name
Negative-pressure wound therapy system dressing set
Device name
Avelle Dressings
Model / reference
421552, Avelle Dressings
Primary DI / UDI-DI
00768455139255
Basic UDI-DI
768455AWC00033C
510(k) Number
FDA product code
OMP
EMDN code
M04010201 Non-woven fixing dressings
GMDN term
Negative-pressure wound therapy system dressing set
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4780
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Size
Width — 16 Centimeter
Length — 16 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

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

Related devices

Category: Negative-pressure wound therapy system dressing set

Cleared under the same submission (K180205)

and 3 more cleared under K180205

Similar devices in this category

Other devices filed under NON-WOVEN FIXING DRESSINGS.

Other devices from Convatec, Purchasing Department

See all devices from Convatec, Purchasing Department →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)