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Avelle 446650

by Convatec, Purchasing Department

Ref 446650Model Avelle Accessories

Avelle 446650 is a personal device holder (EU MDR Class I; FDA Class II; FDA product code OMP, Negative Pressure Wound Therapy Powered Suction Pump) made by Convatec, Purchasing Department, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI 768455AWC000138) and listed in FDA GUDID since 22 Feb 2023 (UDI-DI 00768455201303), active as of 24 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number768455AWC000138 Basic UDI-DI 00768455201303UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00768455201303 UDI-DI Date22 Feb 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 768455AWC000138 registered 7 Oct 2026 Active
  • FDA GUDID UDI-DI 00768455201303 listed 22 Feb 2023 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 00768455201303
  2. Registered EUDAMED 768455AWC000138

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Avelle
Generic name
Personal device holder, single-use
Device name
Avelle Accessories
Model / Ref / Catalog
446650, Avelle Accessories
Primary DI / UDI-DI
00768455201303
Basic UDI-DI
768455AWC000138
FDA product code
OMP
EMDN code
Z12019003 Wound treatment equipment
GMDN term
Personal device holder, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4780
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Personal device holder, single-use

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
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)