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Extension Cable for Goggles

by Natus Manufacturing Limited

Ref 9031E2722

Extension Cable for Goggles (9031E2722) is a device classified as Class I in the EU and Class II in the US made by Natus Manufacturing Limited, registered in EUDAMED on 2 May 2024 (Basic UDI-DI 0382830059077UC), cleared under FDA 510(k) K944547 on 19 Sep 1995 and listed in FDA GUDID since 8 Jul 2020 (UDI-DI 00382830047722), active (EUDAMED, FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US), not in commercial distribution.

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K944547

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0382830059077UC Basic UDI-DI 00382830047722UDI-DIDate2 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00382830047722 UDI-DI Date8 Jul 2020ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK944547 Date19 Sep 1995DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0382830059077UC registered 2 May 2024 Active
  • FDA 510(k) K944547 decided 19 Sep 1995 Active
  • FDA GUDID UDI-DI 00382830047722 listed 8 Jul 2020 Listed

Recalls

1 recall · FDA

    • Terminated Z-1407-2013 FDA Class II initiated 9 Apr 2013

    Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the presence of a software bug.

Timeline

4 dated events

  1. Cleared FDA 510(k) K944547
  2. Recall initiated FDA recalls Z-1407-2013
  3. Listed FDA GUDID 00382830047722
  4. Registered EUDAMED 0382830059077UC

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Extension Cable for Goggles EUDAMED
Natus GUDID
Generic name
Electromyograph
Device name
Keypoint Class 1 Accessories
Model / reference
9031E2722
Primary DI / UDI-DI
00382830047722
Basic UDI-DI
0382830059077UC
FDA product code
GWF
EMDN code
Z12100480 Electromyography instruments - hardware accessories
GMDN term
Electromyograph
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1870
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
IE-MF-000000799

Similar devices in this category

Other devices filed under ELECTROMYOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Natus Manufacturing Limited

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Properties

  • Lot / batch number
Other properties (24, all answered No)