2001

Nom de l'organisation

Tindaya s.r.o.

SRN

CZ-MF-000051158

Statut du fabricant

Actif

Marché principal en Tchéquie ; disponible dans 30 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

08594231440008

Basic UDI-DI

859423144NISICLB

Numéro de référence/catalogue

2001

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

Intended Purpose: The NISIC Digital Optotype is a medical device intended for examination of visual functions in patients of all age groups. It consists of Apple iPad A16 hardware and software, which comprises two iOS modules: NISIC server (cz.tindaya.nisic) and R4NISIC remote (cz.tindaya.r4nisic2). The device enables the performance of standardized tests of distance and near visual acuity, tests of binocular vision, fusion and stereopsis, color vision tests, screening tests for astigmatism and other supplementary eye examinations. The NISIC Digital Optotype is intended for eye examination in patients of all age groups, from preschool children to seniors. The device is applicable in persons with suspected reduced visual acuity, with refractive errors (myopia, hyperopia, astigmatism, presbyopia), with disorders of binocular or color vision and in monitoring visual changes related to retinal diseases. The device is intended to be used by a healthcare professional or under their supervision in ophthalmological and optometric practices, in general practitioner offices and during preventive examinations.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Q0299OPHTHALMIC DEVICES - OTHER

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