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Trigen Max 72502003

by Smith & Nephew, Inc.

Ref 72502003

Trigen Max 72502003 is a device classified as Class I in the EU and Class II in the US made by Smith & Nephew, Inc., registered in EUDAMED on 9 Sep 2026 (Basic UDI-DI 0885556SN000381M7) and listed in FDA GUDID since 7 May 2025 (UDI-DI 00885556895757), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0885556SN000381M7 Basic UDI-DI 00885556895757UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00885556895757 UDI-DI Date7 May 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0885556SN000381M7 registered 9 Sep 2026 Active
  • FDA GUDID UDI-DI 00885556895757 listed 7 May 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00885556895757
  2. Registered EUDAMED 0885556SN000381M7

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  • Withdrawn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
Trigen Max
Generic name
Orthopaedic bone-reduction tool
Device name
Memphis Class IR SNOI-TF-028 L090999
Model / Ref / Catalog
72502003
Primary DI / UDI-DI
00885556895757
Basic UDI-DI
0885556SN000381M7
FDA product code
HSB
EMDN code
L090999 Orthopaedic surgery cutting instruments, reusable - other
GMDN term
Orthopaedic bone-reduction tool
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3020
EU registration type
Standard device
EU market of registration
Netherlands
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 I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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 bone-reduction tool

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER.

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

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