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EBA2 Cannulated drill bit

by Citieffe

Ref EBA-5205Model Reamers and drill bits

EBA2 Cannulated drill bit (EBA-5205) is a device classified as Class IIa in the EU and Class II in the US made by Citieffe, registered in EUDAMED on 15 Sep 2026 (Basic UDI-DI 803290962102BJ), cleared under FDA 510(k) K131005 on 25 Jun 2013 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 08032909627851), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K131005

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803290962102BJ Basic UDI-DI 08032909627851UDI-DIDate15 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08032909627851 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK131005 Date25 Jun 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 803290962102BJ registered 15 Sep 2026 Active
  • FDA 510(k) K131005 decided 25 Jun 2013 Active
  • FDA GUDID UDI-DI 08032909627851 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K131005
  2. Listed FDA GUDID 08032909627851
  3. Registered EUDAMED 803290962102BJ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Surgical Instruments (Iia) EUDAMED
EBA2 GUDID
Generic name
Cannulated surgical drill bit, reusable
Model / Ref / Catalog
Reamers and drill bits, EBA-5205, Cannulated drill bit
Primary DI / UDI-DI
08032909627851
Basic UDI-DI
803290962102BJ
Direct marketing DI
08032909627851
510(k) Number
FDA product code
HSB
EMDN code
L0916 Orthopaedic surgery burs and tips, reusable
GMDN term
Cannulated surgical drill bit, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3020
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Reamers and drill bits
EBA-5205
GUDID
Cannulated drill bit
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Cannulated surgical drill bit, reusable

Cleared under the same submission (K131005)

and 8 more cleared under K131005

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE.

Other devices from Citieffe

See all devices from Citieffe →

Properties

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