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Gun-01

by Tecres

Ref GUN-01

Gun-01 is a Class I device made by Tecres, registered in EUDAMED on 1 Sep 2026 (Basic UDI-DI 80314970601NW) and listed in FDA GUDID since 23 Sep 2022 (UDI-DI 08031497002187), active as of 9 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 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number80314970601NW Basic UDI-DI 08031497002187UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08031497002187 UDI-DI Date23 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 80314970601NW registered 1 Sep 2026 Active
  • FDA GUDID UDI-DI 08031497002187 listed 23 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08031497002187
  2. Registered EUDAMED 80314970601NW

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  • Withdrawn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

Generic name
Orthopaedic implantable material dispenser, cartridge-/syringe-accepting, reusable
Device name
Guns
Model / reference
GUN-01
Primary DI / UDI-DI
08031497002187
Basic UDI-DI
80314970601NW
Direct marketing DI
08031497002187
FDA product code
KIH
EMDN code
P099002 Orthopaedic cement preparation and application devices and kits
GMDN term
Orthopaedic implantable material dispenser, cartridge-/syringe-accepting, reusable
Device class
Class I
Regulation number
888.4200
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic cement/bone filler dispensing gun

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

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)