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522625

by inomed Medizintechnik GmbH

Ref 522625

522625 is a device classified as Class III in the EU and Class II in the US made by inomed Medizintechnik GmbH, registered in EUDAMED on 7 Sep 2026 (Basic UDI-DI B-04250307602629) and listed in FDA GUDID since 11 Feb 2022 (UDI-DI 04250307602629), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04250307602629 Basic UDI-DI 04250307602629UDI-DIDate7 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250307602629 UDI-DI Date11 Feb 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04250307602629 registered 7 Sep 2026 Active
  • FDA GUDID UDI-DI 04250307602629 listed 11 Feb 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250307602629
  2. Registered EUDAMED B-04250307602629

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  • Withdrawn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
Hakensonde 35mm bipolar, gerade
Generic name
Nerve-locating system probe, single-use
Model / reference
522625
Primary DI / UDI-DI
04250307602629
Basic UDI-DI
B-04250307602629
FDA product code
GWF, ETN
EMDN code
N010180 Neurophysiology devices - accessories
GMDN term
Nerve-locating system probe, single-use
Device class
Class III EUDAMED
Class II GUDID
Regulation number
882.1870, 874.1820
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Nerve-locating system probe, single-use

Similar devices in this category

Other devices filed under NEUROPHYSIOLOGY DEVICES - ACCESSORIES.

Other devices from inomed Medizintechnik GmbH

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)