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Cemex Prep Kit KIT-01

by Tecres

Ref KIT-01

Cemex Prep Kit KIT-01 is a device classified as Class IIb in the EU and Class II in the US made by Tecres, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 80314970606P8), cleared under FDA 510(k) K021765 on 16 Aug 2002 and listed in FDA GUDID since 8 Oct 2015 (UDI-DI 28031497000323), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K021765

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number80314970606P8 Basic UDI-DI 28031497000323UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number28031497000323 UDI-DI Date8 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK021765 Date16 Aug 2002DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 80314970606P8 registered 30 Oct 2026 Active
  • FDA 510(k) K021765 decided 16 Aug 2002 Active
  • FDA GUDID UDI-DI 28031497000323 listed 8 Oct 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K021765
  2. Listed FDA GUDID 28031497000323
  3. Registered EUDAMED 80314970606P8

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Cemex Prep Kit
Generic name
Orthopaedic cement preparation/delivery kit
Model / reference
KIT-01
Primary DI / UDI-DI
28031497000323
Basic UDI-DI
80314970606P8
510(k) Number
FDA product code
JDK
EMDN code
P099002 Orthopaedic cement preparation and application devices and kits
GMDN term
Orthopaedic cement preparation/delivery kit
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.3300
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic cement preparation/delivery kit

Cleared under the same submission (K021765)

and 1 more cleared under K021765

Other devices from Tecres

See all devices from Tecres →

Properties

  • Supplied sterile
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Sutures
  • Contains animal tissues or cells
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)