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Purekit

by Teknimed SAS

Ref T060425Model Mixing and injection system for bone cement

Purekit (T060425) 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 3 May 2022 (UDI-DI 03760177045217), 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 Number376017704B33D7 Basic UDI-DI 03760177045217UDI-DIDate18 Apr 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number03760177045217 UDI-DI Date3 May 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 376017704B33D7 registered 18 Apr 2023 Active
  • FDA GUDID UDI-DI 03760177045217 listed 3 May 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03760177045217
  2. Registered EUDAMED 376017704B33D7

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  • Withdrawn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
Purekit EUDAMED
Pure Kit GUDID
Generic name
Orthopaedic cement preparation/delivery kit
Model / reference
Mixing and injection system for bone cement, T060425
Primary DI / UDI-DI
03760177045217
Basic UDI-DI
376017704B33D7
FDA product code
OAR, JDZ
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, 888.4210
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)