Skip to content

ArTT 9055.34.309

by Limacorporate

Part of a family of 315 devices: see the family page

Ref 9055.34.309Model 80333902A040BL

ArTT 9055.34.309 is a device classified as Class IIa in the EU and Class I in the US made by Limacorporate, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI 80333902A040BL) and listed in FDA GUDID since 25 Sep 2025 (UDI-DI 08033390304856), 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 Number80333902A040BL Basic UDI-DI 08033390304856UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033390304856 UDI-DI Date25 Sep 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 80333902A040BL registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 08033390304856 listed 25 Sep 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08033390304856
  2. Registered EUDAMED 80333902A040BL

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  • Withdrawn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
General Instrument - Drill Guide, Bowed, 10mm Collar Dia.4,5mm EUDAMED
ArTT GUDID
Generic name
Surgical drill guide, reusable
Model / Ref / Catalog
9055.34.309, 80333902A040BL
Primary DI / UDI-DI
08033390304856
Basic UDI-DI
80333902A040BL
FDA product code
FZX
EMDN code
L0922 Orthopaedic surgery guides, reusable
GMDN term
Surgical drill guide, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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.

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY GUIDES, REUSABLE.

Other devices from Limacorporate

See all devices from Limacorporate →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)