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Valves

by Trulife Inc. 4 variants

Part of a family of 9 devices: see the family page

Ref AEV35K

Valves (AEV35K) is a Class I device made by Trulife Inc., registered in EUDAMED on 22 Jun 2026 (Basic UDI-DI 00645517ValveVY), active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number00645517ValveVY Basic UDI-DI 00645517888699UDI-DIDate22 Jun 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Valves
Model / reference
AEV35K
Primary DI / UDI-DI
00645517888699
Basic UDI-DI
00645517ValveVY
EMDN code
Y062499 Lower extremity prostheses - other
Device class
Class I
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000009657
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under EXTERNAL PROSTHESES AND ORTHOSES.

Other devices from Trulife Inc.

See all devices from Trulife Inc. →

Properties

Other properties (14, all answered No)