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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

BIOM 7.8 — Class IIa MDR by EKOVUK MEDI, s.r.o.

MD Atlas
EKOVUK MEDI, s.r.o.

EUDAMED last updated this device on Jan 15, 2026

BIOM 7.8

859421244BIOMHL

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: EKOVUK MEDI, s.r.o.
UDI-DI code: 08594212440164
Reference / catalog number: BIOM 7.8

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Manufacturer information

Organization name: EKOVUK MEDI, s.r.o.
SRN: CZ-MF-000040403
Manufacturer status: Active

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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.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement	Jan 1, 2026	Still on market
Slovakia	Jan 1, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08594212440164
Basic UDI-DI: 859421244BIOMHL
Reference / catalog number: BIOM 7.8
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Medical device to be used for non-invasive diagnostics, screening and monitoring of the vascular system and microcirculation
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12099001BODY IMPEDANCE ANALYSERS

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
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Software identification