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530626

by inomed Medizintechnik GmbH

Ref 530626

530626 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 16 Sep 2026 (Basic UDI-DI B-04250307603305) and listed in FDA GUDID since 12 Oct 2023 (UDI-DI 04250307603305), 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-04250307603305 Basic UDI-DI 04250307603305UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250307603305 UDI-DI Date12 Oct 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04250307603305 registered 16 Sep 2026 Active
  • FDA GUDID UDI-DI 04250307603305 listed 12 Oct 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250307603305
  2. Registered EUDAMED B-04250307603305

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  • Withdrawn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
SDN Elektroden RT/SW 20/1200, Edelstahl
Generic name
Electromyographic needle electrode, single-use
Model / reference
530626
Primary DI / UDI-DI
04250307603305
Basic UDI-DI
B-04250307603305
FDA product code
GWF, ETN
EMDN code
N010180 Neurophysiology devices - accessories
GMDN term
Electromyographic needle electrode, single-use
Device class
Class IIa 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 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: Electromyographic needle electrode, 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)