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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

LATEX EXAMINATION GLOVES, POWDER… — Class I MDR

MD Atlas
VULKAN - Medical, a.s.

EUDAMED last updated this device on Jan 15, 2026

LATEX EXAMINATION GLOVES, POWDER FREE,DONA SENSIplus

859420032LAT2EM

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: VULKAN - Medical, a.s.
UDI-DI code: 08594200323165
Reference / catalog number: 9012-S-E

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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

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

CW009
EUDAMED did not publish a description for this code.
CW999
This product contains natural latex, other components or used auxiliary materials during the production may cause allergic reaction in the case of hypersensitivity. Avoid contact with petroleum-based products and grease. Glove life depends upon storage and wearing conditions. The user should make a visual inspection before using the gloves and discard them if damaged. 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.

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: LATEX EXAMINATION GLOVES, POWDER FREE,DONA SENSIplus
UDI-DI code: 08594200323165
Basic UDI-DI: 859420032LAT2EM
Reference / catalog number: 9012-S-E
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) / SMALL / MALÉ

EMDN nomenclature code(s)

T010201LATEX 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

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Software identification