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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

N/A — Class I MDR by MEDDI hub a.s.

MD Atlas
MEDDI hub a.s.

EUDAMED last updated this device on Apr 2, 2026

N/A

859423233BIOSCAN01GQ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MEDDI hub a.s.
UDI-DI code: 08594232330001
Reference / catalog number: N/A

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Manufacturer information

Organization name: MEDDI hub a.s.
SRN: CZ-MF-000036762
Manufacturer status: Active

Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement	Apr 17, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08594232330001
Basic UDI-DI: 859423233BIOSCAN01GQ
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: BioScan is a medical device software intended for user-initiated, non-invasive self-measurement of selected physiological parameters by laypersons using remote photoplethysmography (rPPG) via compatible mobile devices equipped with a camera. The device provides outputs for health awareness only and is intended to support personal self-monitoring of physiological parameters without clinical interpretation. It is not intended to provide a diagnosis, to replace medical examinations or professional medical advice, or to be used for clinical decision-making. The information provided may encourage users to consult a qualified healthcare professional if they have health-related concerns. It does not replace measurements obtained using clinically validated medical devices and/or methods used as part of established standards of care and shall not be used as a substitute for such devices and/or methods. The user is not intended to interpret or take clinical action based on the device output without consultation with a qualified healthcare professional.
Additional information URL: https://www.meddiapp.com/bioscan-navod.pdf
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12030292VITAL SIGNS MONITORING INSTRUMENTS - 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

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.