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Ratchet Handle

by Teknimed SAS

Part of a family of 57 devices: see the family page

Ref T067228Model Reusable Surgical Instruments

Ratchet Handle (T067228) is a Class I device made by Teknimed, registered in EUDAMED on 2 Jan 2025 (Basic UDI-DI 376017704B27DC) and listed in FDA GUDID since 22 Jan 2024 (UDI-DI 03701505800139), active as of 25 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number376017704B27DC Basic UDI-DI 03701505800139UDI-DIDate2 Jan 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number03701505800139 UDI-DI Date22 Jan 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 376017704B27DC registered 2 Jan 2025 Active
  • FDA GUDID UDI-DI 03701505800139 listed 22 Jan 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03701505800139
  2. Registered EUDAMED 376017704B27DC

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  • Withdrawn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

Generic name
Surgical screwdriver, reusable
Model / Ref / Catalog
Reusable Surgical Instruments, T067228
Primary DI / UDI-DI
03701505800139
Basic UDI-DI
376017704B27DC
Direct marketing DI
03701505800139
FDA product code
HXX
EMDN code
L091099 Osteosynthesis instruments, reusable - other
GMDN term
Surgical screwdriver, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
FR-MF-000001224

Related devices

Category: Surgical implant template, reusable

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Teknimed

See all devices from Teknimed →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)