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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

8594205375978 — Class I MDR by Balerina-Czech, s.r.o.

MD Atlas
Balerina-Czech, s.r.o.

EUDAMED last updated this device on Jan 19, 2026

8594205375978

859420537PFHM933RC

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Balerina-Czech, s.r.o.
UDI-DI code: 08594205375978
Reference / catalog number: 8594205375978

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Manufacturer information

Organization name: Balerina-Czech, s.r.o.
SRN: CZ-MF-000050806
Manufacturer status: Active

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8594205377347859420537BFE99CAOn the market 8594205377316859420537BFE99CAOn the market 8594205377286859420537BFE99CAOn the market 8594205377255859420537BFE99CAOn the market 8594205377248859420537BFE99CAOn the market

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.

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: 08594205375978
Basic UDI-DI: 859420537PFHM933RC
Reference / catalog number: 8594205375978
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: 5
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T020699MEDICAL USE FACE MASKS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - 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