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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

Vinyl examination gloves, VinylDona — Class I MDR

MD Atlas
VULKAN - Medical, a.s.

EUDAMED last updated this device on Apr 20, 2026

Vinyl examination gloves, VinylDona

859420032VIN1HF

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: VULKAN - Medical, a.s.
UDI-DI code: 08594200320331
Reference / catalog number: 9011-S

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Manufacturer information

Organization name: VULKAN - Medical, a.s.
SRN: CZ-MF-000016349
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW009
EUDAMED did not publish a description for this code.
CW999
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State. This product does not contain natural rubber latex, For minimal risk only. Don the gloves only on clean, dry hands. For prolonged or demanding procedures, replace them more frequently. Certain components or auxiliary materials used in the manufacturing process may elicit allergic reactions in sensitive individuals. Should any irritation occur, discontinue use and seek medical advice.

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: Vinyl examination gloves, VinylDona
UDI-DI code: 08594200320331
Basic UDI-DI: 859420032VIN1HF
Reference / catalog number: 9011-S
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: 100
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: S(7)/ MALÉ / SMALL

EMDN nomenclature code(s)

T01020201VINYL EXAMINATION / TREATMENT GLOVES

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

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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.