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5400007000

by Stryker Corp.

Ref 5400-007-000Model 08858250000629S9

5400007000 is a device classified as Class I in the EU and Class II in the US made by Stryker Corp., registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 08858250000629S9) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 07613154879205), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858250000629S9 Basic UDI-DI 07613154879205UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613154879205 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858250000629S9 registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 07613154879205 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613154879205
  2. Registered EUDAMED 08858250000629S9

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  • Withdrawn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

Generic name
Foot-switch, electrical
Device name
Console Foot Switch
Model / Ref / Catalog
08858250000629S9 EUDAMED
5400-007-000 EUDAMED
5400007000 GUDID
Primary DI / UDI-DI
07613154879205
Basic UDI-DI
08858250000629S9
Direct marketing DI
07613154879205
FDA product code
DZJ
EMDN code
Z12019080 Various instruments for general and multidisciplinary surgery - hardware accessories
GMDN term
Foot-switch, electrical
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.4120
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858250000629S9
5400-007-000
GUDID
5400007000
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

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - HARDWARE ACCESSORIES.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)