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DWD065

by Tornier, Inc.

Ref DWD065Model 08858251028067UJ

DWD065 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 08858251028067UJ) and listed in FDA GUDID since 8 Aug 2022 (UDI-DI 03700386931819), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251028067UJ Basic UDI-DI 03700386931819UDI-DIDate13 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700386931819 UDI-DI Date8 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251028067UJ registered 13 Aug 2026 Active
  • FDA GUDID UDI-DI 03700386931819 listed 8 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03700386931819
  2. Registered EUDAMED 08858251028067UJ

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  • Withdrawn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
Generic name
Orthopaedic implant calibration pin
Device name
Aequalis Reversed II Instrumentation - Guide-Wires, K-Wires, Pins - Class Iia - Sterile
Model / Ref / Catalog
DWD065, 08858251028067UJ
Primary DI / UDI-DI
03700386931819
Basic UDI-DI
08858251028067UJ
FDA product code
HWE
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
Orthopaedic implant calibration pin
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
Size
Length — 150 Millimeter
Outer Diameter — 2.5 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: Orthopaedic implant calibration pin

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)