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Sphinx CU710 Control Unit

by Neurotronics, LLC

Ref CU710Model Sphinx PMU710

Sphinx CU710 Control Unit is a device classified as Class IIa in the EU and Class II in the US made by Neurotronics, LLC, registered in EUDAMED on 15 Aug 2023 (Basic UDI-DI B-00817111020205), cleared under FDA 510(k) K142774 on 18 Feb 2015 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00817111020205), active as of 22 Oct 2026.

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

CE MDD 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) K142774

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/MDD EUDAMED NumberB-00817111020205 Basic UDI-DI 00817111020205UDI-DIDate15 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00817111020205 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK142774 Date18 Feb 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00817111020205 registered 15 Aug 2023 Active
  • FDA 510(k) K142774 decided 18 Feb 2015 Active
  • FDA GUDID UDI-DI 00817111020205 listed 22 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K142774
  2. Listed FDA GUDID 00817111020205
  3. Registered EUDAMED B-00817111020205

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Polysomnograph
Model / reference
Sphinx PMU710, CU710
Primary DI / UDI-DI
00817111020205
Basic UDI-DI
B-00817111020205
510(k) Number
FDA product code
OLZ, OLV, DQA
EMDN code
Z12100501 Polysomnographs
GMDN term
Polysomnograph
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.1400, 870.2700
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

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.

Manufacturer details

EUDAMED SRN
US-MF-000030839
Authorised representative
NIHON KOHDEN EUROPE GmbH DE-AR-000010740

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)