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Organization name
UDI-DI code
Reference / catalog number

2.01.500 — Class I MDR by Univerzita Tomáše Bati…

MD Atlas
Univerzita Tomáše Bati ve Zlíně

EUDAMED last updated this device on Apr 24, 2026

2.01.500

859420918SONOGEL94

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Univerzita Tomáše Bati ve Zlíně
UDI-DI code: 18594209180018
Reference / catalog number: 2.01.500

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Manufacturer information

Organization name: Univerzita Tomáše Bati ve Zlíně
SRN: CZ-MF-000053367
Manufacturer status: Active

Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 18594209180018
Basic UDI-DI: 859420918SONOGEL94
Reference / catalog number: 2.01.500
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: Jednorázové použití pro ultrazvukovou diagnostiku, ultrazvukové vyšetření / gynekologické vyšetření. Médium pro zabezpečení lepšího kontaktu a podmínek pro vysílání a příjem ultrazvukových vln, které procházejí přes kůži během ultrazvukového vyšetření. Aplikuje se na části lidského těla nebo sondy před sonografickým vyšetřením. Po použití nelze tento prostředek znovu použít. Gel je vodorozpustný, není dráždivý a nepoškozuje sondy.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11049099VARIOUS ULTRASOUND INSTRUMENTS - OTHER

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.