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Trulife SEC201-22R

by Trulife Inc.

Part of a family of 36 devices: see the family page

Ref SEC201-22R

Trulife SEC201-22R is a Class I device made by Trulife Inc., registered in EUDAMED on 7 May 2026 (Basic UDI-DI 00645517CosmesisCG) and listed in FDA GUDID since 31 Dec 2022 (UDI-DI 00645517377520), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number00645517CosmesisCG Basic UDI-DI 00645517377520UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00645517377520 UDI-DI Date31 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 00645517CosmesisCG registered 7 May 2026 Active
  • FDA GUDID UDI-DI 00645517377520 listed 31 Dec 2022 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 00645517377520
  2. Registered EUDAMED 00645517CosmesisCG

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  • Withdrawn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
Trulife
Generic name
External limb prosthesis finishing component, non-customized
Device name
SEC2 Endoskeletal Cosmesis
Model / reference
SEC201-22R
Primary DI / UDI-DI
00645517377520
Basic UDI-DI
00645517CosmesisCG
FDA product code
ISH
EMDN code
Y062499 Lower extremity prostheses - other
GMDN term
External limb prosthesis finishing component, non-customized
Device class
Class I
Regulation number
890.3420
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: External limb prosthesis finishing component, non-customized

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

  • Single use
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)