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Aequalis Reversed II MWD318

by Tornier, Inc.

Ref MWD318Model 08858251027969VU

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251027969VU Basic UDI-DI 03700386972522UDI-DIDate13 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700386972522 UDI-DI Date8 Aug 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Bone cutter
Device Name
Aequalis Reversed II Instrumentation - Cutting Guides - Class Iia - Non Sterile
Model / Ref / Catalog
MWD318, 08858251027969VU
Primary DI / UDI-DI
03700386972522
Basic UDI-DI
08858251027969VU
FDA Product Code
HWE
EMDN Code
L091104 Orthopaedic prostheses positioners, reusable
GMDN Term
Bone cutter
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4820
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Bone cutter

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

  • CMR Substance
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No