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ExtriCARE MI425-0001

by Alleva Medical Limited

Ref MI425

ExtriCARE MI425-0001 (EC1000-CAN) 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 489708907MI425KE), cleared under FDA 510(k) K213906 on 8 Mar 2023 and listed in FDA GUDID since 28 Dec 2023 (UDI-DI 04897089070477), active as of 12 Nov 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 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K213906

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number489708907MI425KE Basic UDI-DI 04897089070477UDI-DIDate2 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04897089070477 UDI-DI Date28 Dec 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK213906 Date8 Mar 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 489708907MI425KE registered 2 Jul 2026 Active
  • FDA 510(k) K213906 decided 8 Mar 2023 Active
  • FDA GUDID UDI-DI 04897089070477 listed 28 Dec 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K213906
  2. Listed FDA GUDID 04897089070477
  3. Registered EUDAMED 489708907MI425KE

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  • Withdrawn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
extriCARE® 1000 Negative Pressure Wound Therapy Pump 50cc Canister EUDAMED
ExtriCARE GUDID
Generic name
Negative-pressure wound therapy system canister
Model / Ref / Catalog
MI425 EUDAMED
MI425-0001 GUDID
EC1000-CAN GUDID
Primary DI / UDI-DI
04897089070477
Basic UDI-DI
489708907MI425KE
Direct marketing DI
04897089070477
510(k) Number
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
MI425
GUDID
MI425-0001
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)