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ArTT 9055.34.105

by Limacorporate

Part of a family of 53 devices: see the family page

Ref 9055.34.105Model 80333902A005BJ

ArTT 9055.34.105 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 80333902A005BJ) and listed in FDA GUDID since 25 Sep 2025 (UDI-DI 08033390287722), 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 Number80333902A005BJ Basic UDI-DI 08033390287722UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033390287722 UDI-DI Date25 Sep 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 80333902A005BJ registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 08033390287722 listed 25 Sep 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08033390287722
  2. Registered EUDAMED 80333902A005BJ

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  • Withdrawn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
ArTT - Long Drill Bit Dia.2.9mm EUDAMED
ArTT GUDID
Generic name
Fluted surgical drill bit, reusable
Model / Ref / Catalog
9055.34.105, 80333902A005BJ
Primary DI / UDI-DI
08033390287722
Basic UDI-DI
80333902A005BJ
FDA product code
HWE
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Fluted surgical drill bit, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
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 PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

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)