Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Disposable Nitrile Examination… — Class I MDR

MD Atlas
VULKAN - Medical, a.s.

EUDAMED last updated this device on Jan 16, 2026

Disposable Nitrile Examination 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: 08594200320591
Reference / catalog number: 9057-XL

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

Disposable nitrile gloves Vulkan Safe859420032NIT5GHOn the market Disposable Nitrile Gloves Vulkan Safe859420032NIT5GHOn the market Disposable Nitrile Gloves Vulkan Safe859420032NIT5GHOn the market Disposable Nitrile Gloves Vulkan Safe859420032NIT5GHOn the market Disposable nitrile gloves VulkanBlack859420032NIT5GHOn 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.

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 Examination Gloves Vulkan Safe
UDI-DI code: 08594200320591
Basic UDI-DI: 859420032NIT5GH
Reference / catalog number: 9057-XL
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: XL(10) / EXTRA LARGE / EXTRA VELKÉ / EXTRA 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
Serial number
Software identification