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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

OS-SPECTRA-001 — Class I MDR by NEXACorteX s.r.o.

MD Atlas
NEXACorteX s.r.o.

EUDAMED last updated this device on Apr 20, 2026

OS-SPECTRA-001

859423500OptoSpecXC

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: NEXACorteX s.r.o.
UDI-DI code: 08594235000000
Reference / catalog number: OS-SPECTRA-001

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Manufacturer information

Organization name: NEXACorteX s.r.o.
SRN: CZ-MF-000053063
Manufacturer status: Active

Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement	Apr 8, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08594235000000
Basic UDI-DI: 859423500OptoSpecXC
Reference / catalog number: OS-SPECTRA-001
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: Non-measuring digital optotype display device intended to present predefined optotype symbols, optotype charts and selected visual test patterns on an electronic screen in healthcare settings. The device is intended to be used by qualified healthcare professionals as a visual display aid. The software controls the presentation of predefined content, including display configuration selected by the user. The device does not measure visual function, does not calculate clinical results, does not record or process patient responses, does not score or evaluate results and does not provide diagnostic output, clinical recommendation or treatment decision. All clinical interpretation and decisions are made solely by the healthcare professional.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z1212012001VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT

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

This device is not currently linked to any other device.

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.