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Organization name
UDI-DI code
Reference / catalog number

N/A — Class I MDR by Tindaya s.r.o.

MD Atlas
Tindaya s.r.o.

EUDAMED last updated this device on Mar 3, 2026

N/A

859423144ViFiAVC

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Tindaya s.r.o.
UDI-DI code: 08594231440039
Reference / catalog number: N/A

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Manufacturer information

Organization name: Tindaya s.r.o.
SRN: CZ-MF-000051158
Manufacturer status: Active

Market distribution

Primary placement in Czechia; available across 1 country total.

Placed on the market in Czechia; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 08594231440039
Basic UDI-DI: 859423144ViFiAVC
Reference / catalog number: N/A
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Intended Purpose: ViFiA is a standalone medical device software (MDSW) intended for the indicative display of a user’s responses to visual stimuli presented in defined areas of the visual field. The software consists of 2 modules - macOS server (cz.tindaya.vifiaserver) a iOS control (cz.tindaya.vifiacontrol) which records the user’s responses to individual visual stimuli and presents these responses graphically to a healthcare professional in the form of a map of detected and undetected stimuli and a time-based record of events. The software does not perform any automatic evaluation, analysis, aggregation, or interpretation of the recorded data, does not compare results with normative values, and does not provide any diagnostic conclusions, classifications, or recommendations regarding the patient’s health condition. The software outputs are intended solely as supportive information for assessment by a healthcare professional and do not replace standard clinical or specialized ophthalmological or neurological examinations. The software is intended exclusively for use by healthcare professionals as part of an indicative assessment of visual functions.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z1212012092INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - MEDICAL DEVICE SOFTWARE

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.