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Alpha ACL-049-M08

by WillowWood Global, LLC

Ref Alpha

Alpha ACL-049-M08 is a device classified as Class I in the EU and Class II in the US made by WillowWood Global, LLC, registered in EUDAMED on 4 Oct 2026 (Basic UDI-DI 0194711linerJ6), cleared under FDA 510(k) K223738 on 11 Jan 2023 and listed in FDA GUDID since 20 Mar 2025 (UDI-DI 00194711116522), 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, self-declared

Class I: no certifier involved

510(k) K223738

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 Number0194711linerJ6 Basic UDI-DI 00194711116522UDI-DIDate4 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00194711116522 UDI-DI Date20 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK223738 Date11 Jan 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0194711linerJ6 registered 4 Oct 2026 Active
  • FDA 510(k) K223738 decided 11 Jan 2023 Active
  • FDA GUDID UDI-DI 00194711116522 listed 20 Mar 2025 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K223738
  2. Listed FDA GUDID 00194711116522
  3. Registered EUDAMED 0194711linerJ6

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  • Withdrawn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
Acl-049-M08 EUDAMED
Alpha GUDID
Generic name
Analytical non-scalp cutaneous electrode
Device name
Alpha Liners
Model / Ref / Catalog
Alpha EUDAMED
ACL-049-M08 GUDID
Primary DI / UDI-DI
00194711116522
Basic UDI-DI
0194711linerJ6
510(k) Number
FDA product code
GXY
EMDN code
Y062409 Transtibial prostheses (for amputation under knee)
GMDN term
Analytical non-scalp cutaneous electrode
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1320
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Alpha
GUDID
ACL-049-M08
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: Analytical non-scalp cutaneous electrode

Cleared under the same submission (K223738)

and 8 more cleared under K223738

Similar devices in this category

Other devices filed under EXTERNAL PROSTHESES AND ORTHOSES.

Other devices from WillowWood Global, LLC

See all devices from WillowWood Global, LLC →

Properties

  • Single use
  • Prescription use
  • Serial number
Other properties (22, all answered No)