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803365

by inomed Medizintechnik GmbH

Ref 803365

803365 is a device classified as Class IIa in the EU and Class II in the US made by inomed Medizintechnik GmbH, registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI B-04250307606221) and listed in FDA GUDID since 27 Sep 2022 (UDI-DI 04250307606221), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04250307606221 Basic UDI-DI 04250307606221UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250307606221 UDI-DI Date27 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04250307606221 registered 23 Sep 2026 Active
  • FDA GUDID UDI-DI 04250307606221 listed 27 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250307606221
  2. Registered EUDAMED B-04250307606221

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Opti-Pin Fixierungspin 70mm
Generic name
Neurological stereotactic surgery system
Model / reference
803365
Primary DI / UDI-DI
04250307606221
Basic UDI-DI
B-04250307606221
FDA product code
HAW
EMDN code
Z12100680 Stereotactic neurosurgery instruments - hardware accessories
GMDN term
Neurological stereotactic surgery system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)