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2Mix ASA0320

by Tecres

Ref ASA0320

2Mix ASA0320 is a device classified as Class IIa in the EU and Class I in the US made by Tecres, registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI 80314970602NY) and listed in FDA GUDID since 12 Feb 2024 (UDI-DI 28031497001078), 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 Number80314970602NY Basic UDI-DI 28031497001078UDI-DIDate1 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number28031497001078 UDI-DI Date12 Feb 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 80314970602NY registered 1 Oct 2026 Active
  • FDA GUDID UDI-DI 28031497001078 listed 12 Feb 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 28031497001078
  2. Registered EUDAMED 80314970602NY

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  • Withdrawn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
2Mix
Generic name
Orthopaedic cement preparation/delivery kit
Model / reference
ASA0320
Primary DI / UDI-DI
28031497001078
Basic UDI-DI
80314970602NY
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 IIa EUDAMED
Class I GUDID
Regulation number
888.4210
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
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)