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Aequalis Reversed II MWB175

by Tornier, Inc.

Ref MWB175Model 08858251028000TJ

Aequalis Reversed II MWB175 is a device classified as Class IIa in the EU and Class I in the US made by Tornier, Inc., registered in EUDAMED on 13 Aug 2026 (Basic UDI-DI 08858251028000TJ) and listed in FDA GUDID since 8 Aug 2022 (UDI-DI 03700386969133), 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 Number08858251028000TJ Basic UDI-DI 03700386969133UDI-DIDate13 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700386969133 UDI-DI Date8 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251028000TJ registered 13 Aug 2026 Active
  • FDA GUDID UDI-DI 03700386969133 listed 8 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03700386969133
  2. Registered EUDAMED 08858251028000TJ

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  • Withdrawn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
Aequalis® Reversed II EUDAMED
Aequalis Reversed II GUDID
Generic name
Humeral head prosthesis trial, reusable
Device name
Aequalis Reversed II Instrumentation - Trialing Instrumentation - Class Iia - Non Sterile
Model / Ref / Catalog
MWB175, 08858251028000TJ
Primary DI / UDI-DI
03700386969133
Basic UDI-DI
08858251028000TJ
FDA product code
LXH
EMDN code
L091104 Orthopaedic prostheses positioners, reusable
GMDN term
Humeral head prosthesis trial, reusable
Device class
Class IIa EUDAMED
Class I GUDID
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
Size
Outer Diameter — 36 Millimeter

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: Humeral head prosthesis trial, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES POSITIONERS, 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)