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X8 System (Sleep Profiler, Sleep Profiler PSG2)

by Advanced Brain Monitoring, Inc. 11 variants

Part of a family of 13 devices: see the family page

Ref SP40-4101

X8 System (Sleep Profiler, Sleep Profiler PSG2) (SP40-4101) is a device classified as Class I in the EU and Class II in the US made by Advanced Brain Monitoring, Inc., registered in EUDAMED on 30 May 2025 (Basic UDI-DI 0851113007SP29ACCTH), cleared under FDA 510(k) K152040 on 30 Oct 2015 (2 earlier submissions) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00851113007215), 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 linked in EUDAMED

A group certificate may exist

510(k) K152040

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0851113007SP29ACCTH Basic UDI-DI 00851113007215UDI-DIDate30 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00851113007215 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK152040 Date30 Oct 2015IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0851113007SP29ACCTH registered 30 May 2025 Active
  • FDA 510(k) K152040 decided 30 Oct 2015 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00851113007215 listed 24 Sep 2016 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K120447
  2. Cleared FDA 510(k) K130013
  3. Cleared FDA 510(k) K152040
  4. Listed FDA GUDID 00851113007215
  5. Registered EUDAMED 0851113007SP29ACCTH

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  • Withdrawn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
X8 System (Sleep Profiler, Sleep Profiler PSG2) EUDAMED
Sleep Profiler GUDID
Generic name
Electrode/transducer strap, reusable
Device name
X8 System
Model / reference
SP40-4101
Primary DI / UDI-DI
00851113007215
Basic UDI-DI
0851113007SP29ACCTH
510(k) Number
FDA product code
OLV, OMC
EMDN code
N01010203 EEG headsets
GMDN term
Electrode/transducer strap, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1400
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
US-MF-000011252
Authorised representative
MPS Medical Product Service GmbH DE-AR-000005009

Similar devices in this category

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Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)