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MWA118

by Tornier, Inc.

Ref MWA118Model 08858251028006TW

MWA118 is a Class I device made by Tornier, Inc., registered in EUDAMED on 24 Aug 2026 (Basic UDI-DI 08858251028006TW) and listed in FDA GUDID since 8 Aug 2022 (UDI-DI 03700386967863), 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 Number08858251028006TW Basic UDI-DI 03700386967863UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700386967863 UDI-DI Date8 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251028006TW registered 24 Aug 2026 Active
  • FDA GUDID UDI-DI 03700386967863 listed 8 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03700386967863
  2. Registered EUDAMED 08858251028006TW

Coverage

2 jurisdictions

United States of AmericaNorwayIcelandSwedenFinlandDenmarkIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicLiechtensteinAustriaHungaryRomaniaPortugalSpainItalyTürkiyeMalta
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Liechtenstein
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Spain
  • Sweden
  • Türkiye

Specification

EUDAMED · GUDID

Trade name
Aequalis® Reversed II
Generic name
Surgical mallet
Device name
Tornier SAS Class I Devices - Impact Instrumentation - Class I - Non-Sterile
Model / Ref / Catalog
MWA118, 08858251028006TW
Primary DI / UDI-DI
03700386967863
Basic UDI-DI
08858251028006TW
FDA product code
HWB
EMDN code
L091101 Orthopaedic prostheses and traumatological implants extractors, reusable
GMDN term
Surgical mallet
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical mallet

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES AND TRAUMATOLOGICAL IMPLANTS EXTRACTORS, REUSABLE.

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

  • Sterilise before use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)