Skip to content

802020

by inomed Medizintechnik GmbH

Ref 802020Model 802010

802020 is a device classified as Class I in the EU and Class II in the US made by inomed Medizintechnik GmbH, registered in EUDAMED on 23 Oct 2025 (Basic UDI-DI 42503076FGS02046) and listed in FDA GUDID since 27 Sep 2022 (UDI-DI 04250307605903), 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 Number42503076FGS02046 Basic UDI-DI 04250307605903UDI-DIDate23 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04250307605903 UDI-DI Date27 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 42503076FGS02046 registered 23 Oct 2025 Active
  • FDA GUDID UDI-DI 04250307605903 listed 27 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250307605903
  2. Registered EUDAMED 42503076FGS02046

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  • Withdrawn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
ZD Befestigungsschiene für offenen Ring
Generic name
Neurological stereotactic surgery system
Device name
ZD-Zielbügeleinheit mit Mikro-metervortrieb, bestehend aus:
Model / reference
802020, 802010
Primary DI / UDI-DI
04250307605903
Basic UDI-DI
42503076FGS02046
Direct marketing DI
04250307605903
FDA product code
IYE
EMDN code
Z12100680 Stereotactic neurosurgery instruments - hardware accessories
GMDN term
Neurological stereotactic surgery system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.5050
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Unsafe

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: Neurological stereotactic surgery system

Similar devices in this category

Other devices filed under STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from inomed Medizintechnik GmbH

See all devices from inomed Medizintechnik GmbH →

Properties

  • Sterilise before use
  • Single use
  • Reusable
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)