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Social Emotional Regulation Assessment (SERA)

by Education, Psychology and Therapy (EPT) Clinic Ltd. 2 variants

Ref SERA-EPT-2025Model V1

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number539155183EPTSERAUH Basic UDI-DI 05391551083204UDI-DIDate30 Jan 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Social Emotional Regulation Assessment (SERA)
Model / Reference
V1, SERA-EPT-2025
Primary DI / UDI-DI
05391551083204
Basic UDI-DI
539155183EPTSERAUH
Direct Marketing DI
05391551083204
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000051074

From the manufacturer

Manufacturer's product page: Emotional Regulation Programme

Other devices from Education, Psychology and Therapy (EPT) Clinic Ltd.

Properties

  • Measuring Function

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No