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Xtruder ASA0390

by Tecres

Ref ASA0390

Xtruder ASA0390 is a device classified as Class IIa in the EU and Class I in the US made by Tecres, registered in EUDAMED on 21 Sep 2026 (Basic UDI-DI 80314970616PB) and listed in FDA GUDID since 23 Sep 2022 (UDI-DI 28031497001436), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number80314970616PB Basic UDI-DI 28031497001436UDI-DIDate21 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number28031497001436 UDI-DI Date23 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 80314970616PB registered 21 Sep 2026 Active
  • FDA GUDID UDI-DI 28031497001436 listed 23 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 28031497001436
  2. Registered EUDAMED 80314970616PB

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  • Withdrawn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
Xtruder
Generic name
Orthopaedic cement preparation/delivery kit
Model / reference
ASA0390
Primary DI / UDI-DI
28031497001436
Basic UDI-DI
80314970616PB
FDA product code
KIH
EMDN code
P099002 Orthopaedic cement preparation and application devices and kits
GMDN term
Orthopaedic cement preparation/delivery kit
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4200
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I 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

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)