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520855

by inomed Medizintechnik GmbH

Ref 520855

520855 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 1 Sep 2026 (Basic UDI-DI B-04250307612086) and listed in FDA GUDID since 2 May 2025 (UDI-DI 04250307612086), 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-04250307612086 Basic UDI-DI 04250307612086UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250307612086 UDI-DI Date2 May 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04250307612086 registered 1 Sep 2026 Active
  • FDA GUDID UDI-DI 04250307612086 listed 2 May 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250307612086
  2. Registered EUDAMED B-04250307612086

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  • Withdrawn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
Tubus-Klebeelektrode Select für Tuben 6-7 mm ID
Generic name
Electromyographic endotracheal tube electrode
Model / reference
520855
Primary DI / UDI-DI
04250307612086
Basic UDI-DI
B-04250307612086
FDA product code
ETN
EMDN code
Z12100480 Electromyography instruments - hardware accessories
GMDN term
Electromyographic endotracheal tube electrode
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
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 endotracheal tube electrode

Similar devices in this category

Other devices filed under ELECTROMYOGRAPHY INSTRUMENTS - HARDWARE 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
  • Manufacturing date
Other properties (17, all answered No)