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EBA ONE Guide wire ø3x800mm (STERILE)

by Citieffe

Ref EBA-5302Model Guide wires

EBA ONE Guide wire ø3x800mm (STERILE) (EBA-5302) 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 803290962107BU), cleared under FDA 510(k) K183666 on 14 Nov 2019 and listed in FDA GUDID since 16 Dec 2019 (UDI-DI 08052990979684), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K183666

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803290962107BU Basic UDI-DI 08052990979684UDI-DIDate15 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08052990979684 UDI-DI Date16 Dec 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK183666 Date14 Nov 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 803290962107BU registered 15 Sep 2026 Active
  • FDA 510(k) K183666 decided 14 Nov 2019 Active
  • FDA GUDID UDI-DI 08052990979684 listed 16 Dec 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K183666
  2. Listed FDA GUDID 08052990979684
  3. Registered EUDAMED 803290962107BU

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  • Withdrawn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
Eba One GUDID
Generic name
Orthopaedic bone wire
Model / Ref / Catalog
Guide wires, EBA-5302, Guide wire ø3x800mm (STERILE)
Primary DI / UDI-DI
08052990979684
Basic UDI-DI
803290962107BU
510(k) Number
FDA product code
HSB
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
Orthopaedic bone wire
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

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Guide wires
EBA-5302
GUDID
Guide wire ø3x800mm (STERILE)
Device classEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Orthopaedic bone wire

Cleared under the same submission (K183666)

and 8 more cleared under K183666

Other devices from Citieffe

See all devices from Citieffe →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)