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Conmed W2000D

by Conmed Corporation

Ref W2000D

Conmed W2000D is a foot-switch (EU MDR Class I; FDA Class II; FDA product code HRX, Arthroscope) made by Conmed Corporation, registered in EUDAMED on 10 Nov 2025 (Basic UDI-DI 084585408588E5), cleared under FDA 510(k) K083161 on 27 Mar 2009 and listed in FDA GUDID since 15 Sep 2020 (UDI-DI 20845854050948), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K083161

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084585408588E5 Basic UDI-DI 20845854050948UDI-DIDate10 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number20845854050948 UDI-DI Date15 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK083161 Date27 Mar 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 084585408588E5 registered 10 Nov 2025 Active
  • FDA 510(k) K083161 decided 27 Mar 2009 Active
  • FDA GUDID UDI-DI 20845854050948 listed 15 Sep 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K083161
  2. Listed FDA GUDID 20845854050948
  3. Registered EUDAMED 084585408588E5

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Conmed
Generic name
Foot-switch, electrical
Device name
Orthopedic, Non-active, Accessory, Footswitch, Wireless
Model / Ref / Catalog
W2000D
Primary DI / UDI-DI
20845854050948
Basic UDI-DI
084585408588E5
Direct marketing DI
10845854050941
510(k) Number
FDA product code
HRX
EMDN code
Z129099 Various instruments for functional exploration and therapeutic interventions - other
GMDN term
Foot-switch, electrical
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.1100
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Foot-switch, electrical

Cleared under the same submission (K083161)

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - OTHER.

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)