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Trulife O10901

by Trulife Inc.

Part of a family of 16 devices: see the family page

Ref O10901

Trulife O10901 is a Class I device made by Trulife Inc., registered in EUDAMED on 7 May 2026 (Basic UDI-DI 00645517Cervical72) and listed in FDA GUDID since 3 Sep 2025 (UDI-DI 00645517323831), 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 Number00645517Cervical72 Basic UDI-DI 00645517323831UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00645517323831 UDI-DI Date3 Sep 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 00645517Cervical72 registered 7 May 2026 Active
  • FDA GUDID UDI-DI 00645517323831 listed 3 Sep 2025 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 00645517323831
  2. Registered EUDAMED 00645517Cervical72

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  • Withdrawn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
Extrication collar, reusable
Device name
Cervical
Model / reference
O10901
Primary DI / UDI-DI
00645517323831
Basic UDI-DI
00645517Cervical72
FDA product code
IQF
EMDN code
Y060312 Cervical spine orthoses
GMDN term
Extrication collar, reusable
Device class
Class I
Regulation number
890.3490
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Head/neck immobilizer, reusable

Similar devices in this category

Other devices filed under CERVICAL SPINE 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)