Skip to content

Avelle 422285

by Convatec, Purchasing Department

Ref 421551Model Avelle Pump

Avelle 422285 is a device classified as Class IIa in the EU and Class II in the US made by Convatec, Purchasing Department, registered in EUDAMED on 9 Oct 2026 (Basic UDI-DI 768455AWC00023A), cleared under FDA 510(k) K180205 on 19 Oct 2018 and listed in FDA GUDID since 9 Sep 2022 (UDI-DI 00768455155033), active as of 25 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 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number768455AWC00023A Basic UDI-DI 00768455155033UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00768455155033 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 768455AWC00023A registered 9 Oct 2026 Active
  • FDA 510(k) K180205 decided 19 Oct 2018 Active
  • FDA GUDID UDI-DI 00768455155033 listed 9 Sep 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K180205
  2. Listed FDA GUDID 00768455155033
  3. Registered EUDAMED 768455AWC00023A

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  • Withdrawn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
Generic name
Negative-pressure wound therapy system pump, electric
Device name
Avelle Pump
Model / reference
Avelle Pump EUDAMED
421551 EUDAMED
422285 GUDID
Primary DI / UDI-DI
00768455155033
Basic UDI-DI
768455AWC00023A
510(k) Number
FDA product code
OMP
EMDN code
Z12019003 Wound treatment equipment
GMDN term
Negative-pressure wound therapy system pump, electric
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4780
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Avelle Pump
421551
GUDID
422285
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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 pump, electric

Cleared under the same submission (K180205)

and 3 more cleared under K180205

Similar devices in this category

Other devices filed under WOUND TREATMENT EQUIPMENT.

Other devices from Convatec, Purchasing Department

See all devices from Convatec, Purchasing Department →

Properties

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