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Tornier Perform™ Humeral System DWT5226

by Tornier, Inc.

Ref DWT5226Model 08858251006936UG

Tornier Perform™ Humeral System DWT5226 is a device classified as Class III in the EU and Class II in the US made by Tornier, Inc., registered in EUDAMED on 26 Aug 2026 (Basic UDI-DI 08858251006936UG) and listed in FDA GUDID since 7 Apr 2022 (UDI-DI 00846832085323), active as of 7 Nov 2026.

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

CE MDR

Valid until

3 Jan 2027

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251006936UG Basic UDI-DI 00846832085323UDI-DIDate26 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00846832085323 UDI-DI Date7 Apr 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251006936UG registered 26 Aug 2026 Active
  • FDA GUDID UDI-DI 00846832085323 listed 7 Apr 2022 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 734563 Expiring Amended Expires in 52 days

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    29 Aug 2024
    Expires
    3 Jan 2027
    Reason
    Mnf data change

Timeline

2 dated events

  1. Listed FDA GUDID 00846832085323
  2. Registered EUDAMED 08858251006936UG

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  • Withdrawn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 Perform™ Humeral System
Generic name
Stem-fixed metallic humeral head prosthesis
Device name
Tornier Perform Humeral System - Humeral Head - TI6AL4V Eli - Class III - Sterile
Model / Ref / Catalog
DWT5226, 08858251006936UG
Primary DI / UDI-DI
00846832085323
Basic UDI-DI
08858251006936UG
FDA product code
HSD, KWT, KWS
EMDN code
P090104010101 Epiphysary humeral components for anatomical prostheses - humeral heads
GMDN term
Stem-fixed metallic humeral head prosthesis
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3690, 888.3650, 888.3660
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Outer Diameter — 52 Millimeter
Height — 26 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Stem-fixed metallic humeral head prosthesis

Similar devices in this category

Other devices filed under EPIPHYSARY HUMERAL COMPONENTS FOR ANATOMICAL PROSTHESES - HUMERAL HEADS.

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)