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Cannula for Knee ASA0010

by Tecres

Ref ASA0010

Cannula for Knee ASA0010 is a device classified as Class IIa in the EU and Class I in the US made by Tecres, registered in EUDAMED on 16 Oct 2026 (Basic UDI-DI B-08031497002217) and listed in FDA GUDID since 23 Sep 2022 (UDI-DI 08031497002217), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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/MDD EUDAMED NumberB-08031497002217 Basic UDI-DI 08031497002217UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08031497002217 UDI-DI Date23 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08031497002217 registered 16 Oct 2026 Active
  • FDA GUDID UDI-DI 08031497002217 listed 23 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08031497002217
  2. Registered EUDAMED B-08031497002217

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Cannula for Knee
Generic name
Orthopaedic cement injection cannula
Device name
Cannulae
Model / reference
ASA0010
Primary DI / UDI-DI
08031497002217
Basic UDI-DI
B-08031497002217
FDA product code
KDD
EMDN code
P099002 Orthopaedic cement preparation and application devices and kits
GMDN term
Orthopaedic cement injection cannula
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4800
EU registration type
Legacy device (under a directive)
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 injection cannula

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 (17, all answered No)