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Darco DC5106

by Wright Medical Technology, Inc.

Ref DC5106

Darco DC5106 is a fluted surgical drill bit (EU MDD Class IIa; FDA Class I; FDA product code GFG, Bit, Surgical) made by Wright Medical Technology, Inc., registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-00840420191922) and listed in FDA GUDID since 17 Sep 2016 (UDI-DI 00840420191922), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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/MDD EUDAMED NumberB-00840420191922 Basic UDI-DI 00840420191922UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840420191922 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00840420191922 registered 5 Nov 2026 Active
  • FDA GUDID UDI-DI 00840420191922 listed 17 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840420191922
  2. Registered EUDAMED B-00840420191922

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Darco
Generic name
Fluted surgical drill bit, reusable
Device name
DARCO 2.0mm Drill Bit
Model / Ref / Catalog
DC5106
Primary DI / UDI-DI
00840420191922
Basic UDI-DI
B-00840420191922
FDA product code
GFG
EMDN code
Z12130503 Orthopaedic surgical drills
GMDN term
Fluted surgical drill bit, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 105 Millimeter

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.

Related devices

Category: Fluted surgical drill bit, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGICAL DRILLS.

Other devices from Wright Medical Technology, Inc.

See all devices from Wright Medical Technology, Inc. →

Properties

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