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Natus Reusable Snap Leads and Natus Disposable Snap Electrodes

by Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)

Ref 1410500

Natus Reusable Snap Leads and Natus Disposable Snap Electrodes (1410500) is a device classified as Class I in the EU and Class II in the US made by Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek), registered in EUDAMED on 15 Jan 2026 (Basic UDI-DI 00382830059022D5), cleared under FDA 510(k) K172703 on 13 Nov 2017 and listed in FDA GUDID since 15 Sep 2021 (UDI-DI 00382830025263), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K172703

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 Number00382830059022D5 Basic UDI-DI 00382830025263UDI-DIDate15 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00382830025263 UDI-DI Date15 Sep 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK172703 Date13 Nov 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 00382830059022D5 registered 15 Jan 2026 Active
  • FDA 510(k) K172703 decided 13 Nov 2017 Active
  • FDA GUDID UDI-DI 00382830025263 listed 15 Sep 2021 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K172703
  2. Listed FDA GUDID 00382830025263
  3. Registered EUDAMED 00382830059022D5

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  • Withdrawn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
Natus Reusable Snap Leads and Natus Disposable Snap Electrodes EUDAMED
Natus GUDID
Generic name
Analytical non-scalp cutaneous electrode
Model / reference
1410500
Primary DI / UDI-DI
00382830025263
Basic UDI-DI
00382830059022D5
Direct marketing DI
00382830025263
510(k) Number
FDA product code
GXY
EMDN code
V9015 Electrodes and probes cutaneous conductive substances
GMDN term
Analytical non-scalp cutaneous electrode
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1320
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
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
CA-MF-000004001
Authorised representative
Natus Manufacturing Ltd IE-AR-000000884

Similar devices in this category

Other devices filed under VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES.

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Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)