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X10 Proxy

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

Ref 2013001

X10 Proxy (2013001) 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 11 Mar 2026 (Basic UDI-DI 038283NA00025E3), cleared under FDA 510(k) K111742 on 31 Aug 2011 and listed in FDA GUDID since 27 Feb 2025 (UDI-DI 00382830023955), active (EUDAMED, FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

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 found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K111742

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 Number038283NA00025E3 Basic UDI-DI 00382830023955UDI-DIDate11 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00382830023955 UDI-DI Date27 Feb 2025ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK111742 Date31 Aug 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 038283NA00025E3 registered 11 Mar 2026 Active
  • FDA 510(k) K111742 decided 31 Aug 2011 Active
  • FDA GUDID UDI-DI 00382830023955 listed 27 Feb 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K111742
  2. Listed FDA GUDID 00382830023955
  3. Registered EUDAMED 038283NA00025E3

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  • Withdrawn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
X10 Proxy EUDAMED
Natus GUDID
Generic name
Polysomnograph
Device name
MDrive Accessories
Model / reference
2013001
Primary DI / UDI-DI
00382830023955
Basic UDI-DI
038283NA00025E3
Direct marketing DI
00382830023955
FDA product code
MNR
EMDN code
Z12100580 Polysomnography instruments - hardware accessories
GMDN term
Polysomnograph
Device class
Class I EUDAMED
Class II GUDID
Regulation number
868.2375
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Contains latexEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Contains latex UDI-DI 00382830023955: EUDAMED states No, FDA GUDID states Yes.

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 POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)

See all devices from Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek) →

Properties

  • Contains latex NoEUDAMEDYesGUDID
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)