Skip to content

530627

by inomed Medizintechnik GmbH

Ref 530627

530627 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-04250307603312) and listed in FDA GUDID since 12 Oct 2023 (UDI-DI 04250307603312), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04250307603312 Basic UDI-DI 04250307603312UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250307603312 UDI-DI Date12 Oct 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04250307603312 registered 16 Sep 2026 Active
  • FDA GUDID UDI-DI 04250307603312 listed 12 Oct 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250307603312
  2. Registered EUDAMED B-04250307603312

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  • Withdrawn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 Elektrode GN 20/1200, Edelstahl
Generic name
Electromyographic needle electrode, single-use
Model / reference
530627
Primary DI / UDI-DI
04250307603312
Basic UDI-DI
B-04250307603312
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

See all devices from inomed Medizintechnik GmbH →

Properties

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