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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

Disposable nitrile gloves Vulkan… — Class I MDR

MD Atlas
VULKAN - Medical, a.s.

EUDAMED last updated this device on Jan 16, 2026

Disposable nitrile gloves Vulkan Safe

859420032NIT5GH

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: VULKAN - Medical, a.s.
UDI-DI code: 08594200320577
Reference / catalog number: 9057-L

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Manufacturer information

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

CW009
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		Still on market
Slovakia		Still on market

Device identification

Trade name: Disposable nitrile gloves Vulkan Safe
UDI-DI code: 08594200320577
Basic UDI-DI: 859420032NIT5GH
Reference / catalog number: 9057-L
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: L (9)/ LARGE / VELKÉ / VEĽKÉ

EMDN nomenclature code(s)

T01020204NITRILE 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
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Software identification