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2178-63-136

by Depuy (Ireland)

Ref 2178-63-136

2178-63-136 (217863136) is a device classified as Class IIa in the EU and Class I in the US made by Depuy (Ireland), registered in EUDAMED on 30 Dec 2025 (Basic UDI-DI 0603295a005669D) and listed in FDA GUDID since 24 Sep 2018 (UDI-DI 10603295096252), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0603295a005669D Basic UDI-DI 10603295096252UDI-DIDate30 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10603295096252 UDI-DI Date24 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0603295a005669D registered 30 Dec 2025 Active
  • FDA GUDID UDI-DI 10603295096252 listed 24 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10603295096252
  2. Registered EUDAMED 0603295a005669D

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  • Withdrawn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

Generic name
Orthopaedic implant-instrument extension adaptor, reusable
Device name
Power Tool Adaptor
Model / Ref / Catalog
2178-63-136, 217863136
Primary DI / UDI-DI
10603295096252
Basic UDI-DI
0603295a005669D
Direct marketing DI
10603295096252
FDA product code
HWE
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic implant-instrument extension adaptor, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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: Orthopaedic implant-instrument extension adaptor, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Depuy (Ireland)

See all devices from Depuy (Ireland) →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)