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ExtriCARE MI424-0001

by Alleva Medical Limited

Ref MI424

ExtriCARE MI424-0001 (EC3000-400C) is a negative-pressure wound therapy system canister (EU MDR Class IIa; FDA Class II; FDA product code OMP, Negative Pressure Wound Therapy Powered Suction Pump) made by Alleva Medical Limited, registered in EUDAMED on 2 Jul 2026 (Basic UDI-DI 489708907MI424KC) and listed in FDA GUDID since 28 Dec 2023 (UDI-DI 04897089070378), active as of 12 Nov 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number489708907MI424KC Basic UDI-DI 04897089070378UDI-DIDate2 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04897089070378 UDI-DI Date28 Dec 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 489708907MI424KC registered 2 Jul 2026 Active
  • FDA GUDID UDI-DI 04897089070378 listed 28 Dec 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04897089070378
  2. Registered EUDAMED 489708907MI424KC

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  • Withdrawn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
extriCARE® 3000 Negative Pressure Wound Therapy Pump 400cc Canister EUDAMED
ExtriCARE GUDID
Generic name
Negative-pressure wound therapy system canister
Model / Ref / Catalog
MI424 EUDAMED
MI424-0001 GUDID
EC3000-400C GUDID
Primary DI / UDI-DI
04897089070378
Basic UDI-DI
489708907MI424KC
Direct marketing DI
04897089070378
FDA product code
OMP
EMDN code
Z12019003 Wound treatment equipment
GMDN term
Negative-pressure wound therapy system canister
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4780
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
MI424
GUDID
MI424-0001
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 canister

Similar devices in this category

Other devices filed under WOUND TREATMENT EQUIPMENT.

Other devices from Alleva Medical Limited

See all devices from Alleva Medical Limited →

Properties

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