Skip to content

Darco DCS2805115

by Wright Medical Technology, Inc.

Ref DCS2805115Model 08858251028036U7

Darco DCS2805115 is a device classified as Class IIb in the EU and Class II in the US made by Wright Medical Technology, Inc., registered in EUDAMED on 14 Oct 2026 (Basic UDI-DI 08858251028036U7) and listed in FDA GUDID since 1 Oct 2015 (UDI-DI 00840420111975), 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 Number08858251028036U7 Basic UDI-DI 00840420111975UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840420111975 UDI-DI Date1 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251028036U7 registered 14 Oct 2026 Active
  • FDA GUDID UDI-DI 00840420111975 listed 1 Oct 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840420111975
  2. Registered EUDAMED 08858251028036U7

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  • Withdrawn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
Darco™ EUDAMED
Darco GUDID
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Device name
Darco Locking Bone Plate Implants - Mpj Plate - Titanium Alloy - Class Iib - Sterile
Model / Ref / Catalog
DCS2805115, 08858251028036U7
Primary DI / UDI-DI
00840420111975
Basic UDI-DI
08858251028036U7
FDA product code
HRS
EMDN code
P09120503 Osteosynthesis screw-plate systems
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Orthopaedic fixation plate, non-bioabsorbable

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS SCREW-PLATE SYSTEMS.

Other devices from Wright Medical Technology, Inc.

See all devices from Wright Medical Technology, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)