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6003-080-001

by Stryker Leibinger

Ref 6003-080-001Model 08858250000566SA

6003-080-001 is a device classified as Class I in the EU and Class II in the US made by Stryker Leibinger, registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI 08858250000566SA) and listed in FDA GUDID since 24 Aug 2016 (UDI-DI 04546540644893), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858250000566SA Basic UDI-DI 04546540644893UDI-DIDate1 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04546540644893 UDI-DI Date24 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858250000566SA registered 1 Oct 2026 Active
  • FDA GUDID UDI-DI 04546540644893 listed 24 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04546540644893
  2. Registered EUDAMED 08858250000566SA

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  • Withdrawn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
Orthopaedic prosthesis implantation positioning instrument, reusable
Model / Ref / Catalog
6003-080-001, 08858250000566SA
Primary DI / UDI-DI
04546540644893
Basic UDI-DI
08858250000566SA
Direct marketing DI
04546540644893
FDA product code
OLO
EMDN code
Z12011480 Surgical navigation instruments - hardware accessories
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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: Orthopaedic prosthesis implantation positioning instrument, reusable

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES.

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Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)