912013060CHES27

Nom de l'organisation

ESD - Evaluation Software Development GmbH

SRN

AT-MF-000042513

Statut du fabricant

Actif

Marché principal en Autriche ; disponible dans 2 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

91201306000530

Basic UDI-DI

912013060CHES27

Numéro de référence/catalogue

 912013060CHES27

Entité d'attribution

GS1

Catégorie de risque

Classe IIa

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The Computer-based Health Evaluation System (CHES) is a web-based platform for efficiently supporting patient-centred care processes in medical facilities (both outpatient and inpatient). CHES is an accessory to CHES.Flag[1]. To this end, CHES offers electronic data collection (including ePROs and electronic case report forms), storage and data analysis based on a modular architecture. CHES is therefore classified as a device class IIa. Standalone use of the accessory CHES is possible; however, it does not constitute an independent medical application within the meaning of the MDR. 1CHES.Flag is a software module, used within the Computer-based Health Evaluation System (CHES). CHES.Flag offers a sophisticated system to facilitate the interpretation of patient-reported outcomes (PROs), collected in CHES, in order to support decisions for diagnostic or therapeutic purposes. As a medical device, it therefore falls under MDR Class IIa. The selection of clinically validated questionnaires is configured by the manufacturer in consultation with the customer to meet its specific needs.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z12040182GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES

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