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Core 5402007000

by Stryker Corp.

Ref 5402-007-000Model 08858250000629S9

Core 5402007000 (5402-007-000) 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 11 Dec 2018 (UDI-DI 07613327423631), 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 07613327423631UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327423631 UDI-DI Date11 Dec 2018ListedStatusListed 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 07613327423631 listed 11 Dec 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327423631
  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  • Withdrawn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

Trade name
Core
Generic name
Foot-switch, electrical
Device name
Console Foot Switch
Model / Ref / Catalog
08858250000629S9, 5402-007-000, 5402007000
Primary DI / UDI-DI
07613327423631
Basic UDI-DI
08858250000629S9
Direct marketing DI
07613327423631
FDA product code
HBE, ERL
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
882.4310, 874.4250
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
5402-007-000
GUDID
5402007000
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
  • Manufacturing date
Other properties (22, all answered No)