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Sigma 96-1674

by Depuy (Ireland)

Ref 96-1674

Sigma 96-1674 (961674) is a Class I device made by Depuy (Ireland), registered in EUDAMED on 13 May 2026 (Basic UDI-DI 0603295a0003283) and listed in FDA GUDID since 24 Sep 2018 (UDI-DI 10603295239796), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0603295a0003283 Basic UDI-DI 10603295239796UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10603295239796 UDI-DI Date24 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0603295a0003283 registered 13 May 2026 Active
  • FDA GUDID UDI-DI 10603295239796 listed 24 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10603295239796
  2. Registered EUDAMED 0603295a0003283

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  • Withdrawn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
Sigma
Generic name
Bone approximation clamp
Device name
Holding Clamp
Model / Ref / Catalog
96-1674, 961674
Primary DI / UDI-DI
10603295239796
Basic UDI-DI
0603295a0003283
Direct marketing DI
10603295239796
FDA product code
HXD
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Bone approximation clamp
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone approximation clamp

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)