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N / a 8000060021

by Stryker Leibinger

Ref 8000-060-021Model 08858250000552RX

N / a 8000060021 (8000-060-021) is a medical device (EU MDR Class I; FDA Class II; FDA product code PGW, Ear, Nose, and Throat Stereotaxic Instrument; EMDN category surgical navigation instruments - hardware accessories) made by Stryker Leibinger, registered in EUDAMED on 7 Jun 2026 (Basic UDI-DI 08858250000552RX) and listed in FDA GUDID since 4 Dec 2020 (UDI-DI 07613327512298), 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 Number08858250000552RX Basic UDI-DI 07613327512298UDI-DIDate7 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327512298 UDI-DI Date4 Dec 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858250000552RX registered 7 Jun 2026 Active
  • FDA GUDID UDI-DI 07613327512298 listed 4 Dec 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327512298
  2. Registered EUDAMED 08858250000552RX

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  • Withdrawn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
N / a
Generic name
Electromagnetic surgical navigation/tracking system
Model / Ref / Catalog
08858250000552RX, 8000-060-021, 8000060021
Primary DI / UDI-DI
07613327512298
Basic UDI-DI
08858250000552RX
Direct marketing DI
07613327512298
FDA product code
PGW
EMDN code
Z12011480 Surgical navigation instruments - hardware accessories
GMDN term
Electromagnetic surgical navigation/tracking system
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858250000552RX
8000-060-021
GUDID
8000060021
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: Electromagnetic surgical navigation device tracking system

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES.

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Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (22, all answered No)