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EBA ONE Diaphyseal trocar, cannulated ø4.2mm

by Citieffe

Ref 08051739539776Model TROCAR

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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K183666

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803290962125BW Basic UDI-DI 08051739539776UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08051739539776 UDI-DI Date4 Jul 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK183666 Date14 Nov 2019DecidedStatusActive

Official records

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

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  • Withdrawn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
Strumenti Chirurgici (Ir) EUDAMED
Eba One GUDID
Generic name
Orthopaedic trocar blade, reusable
Device name
Surgical Instruments (Ir)
Model / Ref / Catalog
TROCAR EUDAMED
08051739539776 EUDAMED
Diaphyseal trocar GUDID
cannulated ø4.2mm GUDID
EBA-5329 GUDID
Primary DI / UDI-DI
08051739539776
Basic UDI-DI
803290962125BW
Direct marketing DI
08051739539776
510(k) Number
FDA product code
HSB
EMDN code
L031205 Orthopaedic surgery trocar, reusable
GMDN term
Orthopaedic trocar blade, reusable
Device class
Class I 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
TROCAR
08051739539776
GUDID
Diaphyseal trocar, cannulated ø4.2mm
Device classEUDAMED
Class I
GUDID
Class II

Related devices

Category: Orthopaedic trocar blade, reusable

Cleared under the same submission (K183666)

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Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date

Other properties (20)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No