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Persyst ESI powered by Epilog v3

by Clouds of Care

Ref PROD01Model v3

Persyst ESI powered by Epilog v3 is a device classified as Class IIa in the EU and Class II in the US made by Clouds of Care, registered in EUDAMED on 13 Jul 2026 (Basic UDI-DI 5430000733PROD01RH) and listed in FDA GUDID since 20 Apr 2026 (UDI-DI 05430000733038), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5430000733PROD01RH Basic UDI-DI Date13 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05430000733038 UDI-DI Date20 Apr 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5430000733PROD01RH registered 13 Jul 2026 Active
  • FDA GUDID UDI-DI 05430000733038 listed 20 Apr 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05430000733038
  2. Registered EUDAMED 5430000733PROD01RH

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Persyst ESI powered by Epilog
Generic name
Electroencephalographic diagnosis-support software
Model / reference
v3, PROD01
Primary DI / UDI-DI
05430000733038, 54300007330386
Basic UDI-DI
5430000733PROD01RH
Direct marketing DI
54300007330386
FDA product code
OLX
EMDN code
Z129092 Various instruments for functional exploration and therapeutic interventions - medical device software
GMDN term
Electroencephalographic diagnosis-support software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.1400
Special device type
Software
EU registration type
Standard device
EU market of registration
Belgium
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.

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE.

Other devices from Clouds of Care

  • PreOp v2

    Class II

  • Persyst ESI powered by Epilog v2

    Class II

  • PreOp v3

    Class II

Properties

  • Prescription use
Other properties (24, all answered No)