SERA-EPT-2025

Nom de l'organisation

Education, Psychology and Therapy (EPT) Clinic Ltd.

SRN

IE-MF-000051074

Statut du fabricant

Actif

Marché principal en Irlande ; disponible dans 1 pays au total.

Commercialisé en Irlande ; dates par pays non publiées.

Dénomination commerciale

non renseigné

Code d'UDI-DI

05391551083204

Basic UDI-DI

539155183EPTSERAUH

Numéro de référence/catalogue

SERA-EPT-2025

Entité d'attribution

GS1

Catégorie de risque

Classe I

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The Social Emotional Regulation Assessment (SERA) is a structured, digital, clinician-led medical software tool completed by parents or caregivers of children and adolescents aged 2–17 years when concerns exist regarding social, emotional, sensory, or regulation development. SERA is intended for use only by qualified healthcare professionals who are appropriately trained, licensed, and registered with a recognised professional or regulatory body, and who work within their professional scope of practice. Authorised users include psychologists, speech and language therapists, occupational therapists, paediatricians, medical doctors, and suitably qualified allied health professionals. The software collects and organises caregiver-reported quantitative and qualitative data relating to regulation. Using predefined, non-adaptive logic, it generates structured profiles, narrative summaries, and visual outputs within a draft clinical report template. Outputs are intended solely to support professional interpretation within a broader clinical assessment and do not provide diagnosis, prognosis, risk assessment, severity determination, or treatment recommendations. SERA is designed for use within clinician-led clinical environments, including outpatient, community, private or public healthcare, telehealth, and ethically governed research settings. Parents complete the assessment digitally; the child does not interact directly with the device. All interpretation and clinical decision-making remain the responsibility of the clinician. SERA supports clinical investigation and understanding rather than diagnostic determination and does not replace standard clinical assessment practices. Cultural context should be considered in interpretation. In accordance with Regulation (EU) 2017/745 and MDCG 2019-11, SERA meets the definition of medical device software under MDR Article 2 and is appropriately classified as a Class I medical device under MDR Rule 11.

URL des informations complémentaires

https://www.eptclinic.ie/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

Ce dispositif n'est actuellement lié à aucun autre dispositif.