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Syringes 4cc

by Teknimed SAS

Ref T060427Model Mixing and injection system for bone cement

Syringes 4cc (T060427) is a Class I device made by Teknimed, registered in EUDAMED on 18 Apr 2023 (Basic UDI-DI 376017704B33D7) and listed in FDA GUDID since 31 Mar 2025 (UDI-DI 03701505801082), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03701505801082 UDI-DI Date31 Mar 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number376017704B33D7 Basic UDI-DI 03701505801082UDI-DIDate18 Apr 2023RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 376017704B33D7 registered 18 Apr 2023 Active
  • FDA GUDID UDI-DI 03701505801082 listed 31 Mar 2025 Listed

Timeline

2 dated events

  1. Registered EUDAMED 376017704B33D7
  2. Listed FDA GUDID 03701505801082

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  • Withdrawn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
Orthopaedic cement preparation/delivery kit
Device name
Purekit
Model / reference
Mixing and injection system for bone cement, T060427
Primary DI / UDI-DI
03701505801082
Basic UDI-DI
376017704B33D7
FDA product code
OAR
EMDN code
P099002 Orthopaedic cement preparation and application devices and kits
GMDN term
Orthopaedic cement preparation/delivery kit
Device class
Class I
Regulation number
888.4200
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
FR-MF-000001224

Similar devices in this category

Other devices filed under ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS.

Other devices from Teknimed

See all devices from Teknimed →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)