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Shakit ASA0380

by Tecres

Ref ASA0380

Shakit ASA0380 is an orthopaedic cement preparation/delivery kit (EU MDR Class I; FDA Class I; FDA product code JDZ, Mixer, Cement, For Clinical Use) made by Tecres, registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI 80314970615P9) and listed in FDA GUDID since 23 Sep 2022 (UDI-DI 28031497001429), 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
European UnionCE/MDR EUDAMED Number80314970615P9 Basic UDI-DI 28031497001429UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number28031497001429 UDI-DI Date23 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 80314970615P9 registered 25 Sep 2026 Active
  • FDA GUDID UDI-DI 28031497001429 listed 23 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 28031497001429
  2. Registered EUDAMED 80314970615P9

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  • Withdrawn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
Shakit
Generic name
Orthopaedic cement preparation/delivery kit
Device name
Mixing Device
Model / reference
ASA0380
Primary DI / UDI-DI
28031497001429
Basic UDI-DI
80314970615P9
FDA product code
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
888.4210
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthopaedic cement preparation/delivery kit

Similar devices in this category

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

Other devices from Tecres

See all devices from Tecres →

Properties

  • Supplied sterile
  • Single use
  • Contains animal tissues or cells
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)