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Tornier Flex MWF067

by Tornier, Inc.

Ref MWF067Model 08858251028110TS

Tornier Flex MWF067 is a device classified as Class IIa in the EU and Class I in the US made by Tornier, Inc., registered in EUDAMED on 24 Aug 2026 (Basic UDI-DI 08858251028110TS) and listed in FDA GUDID since 8 Aug 2022 (UDI-DI 03700386974878), 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 Number08858251028110TS Basic UDI-DI 03700386974878UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700386974878 UDI-DI Date8 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251028110TS registered 24 Aug 2026 Active
  • FDA GUDID UDI-DI 03700386974878 listed 8 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03700386974878
  2. Registered EUDAMED 08858251028110TS

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  • Withdrawn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
Tornier Flex Shoulder System EUDAMED
Tornier Flex GUDID
Generic name
Bone-resection orthopaedic reamer, reusable
Device name
Tornier Flex Shoulder System Instrumentation - Distraction / Retraction Instrumentation - Class Iia - Non Sterile
Model / Ref / Catalog
MWF067, 08858251028110TS
Primary DI / UDI-DI
03700386974878
Basic UDI-DI
08858251028110TS
Direct marketing DI
03700386974878
FDA product code
HWE
EMDN code
L091102 Orthopaedic prostheses reamers and burs, reusable
GMDN term
Bone-resection orthopaedic reamer, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
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 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: Bone-resection orthopaedic reamer, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES REAMERS AND BURS, 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)