VULKAN - Medical, a.s.
CZ-MF-000016349 · Czechia · Hrádek nad Nisou
VULKAN - Medical, a.s. is registered in the European database on medical devices as a manufacturer, with 64 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 64 |
|---|
Devices declared under this manufacturer
- DONA SENSIplus
- Disposable nitrile gloves VulkanBlack
- Jednorázové nitrilové rukavice VulkanPink
- Latex examination gloves, DONA Sensitive, powdered
- Latex examination gloves, DONA Sensitive, powdered[
- Nitrile Examination Gloves DONA
- Nitrile Examination Gloves with long cuff DONA
- Nitrile Examination Gloves with long cuff DONA
- Návleky na lékařské sondy Ø 33 mm, 150 ks / lubrikované
- Návleky na lékařské sondy Ø 33 mm,suché-200 ks v bal.
- Rukavice latexové vyšetřovací SAFETY zesílené, prodloužené
- Rukavice latexové vyšetřovací, bezprašné DONA SENSIplus
Showing 12 of 64 declared devices.
Catalogue references include 9011-M, 9011-M-200, 9012-M, 9012-XL, 9018-S-B, 9018-XS-D.
European nomenclature codes declared: T01020204, T010201, T01020201, T030101,Z11040185.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 64 |
| Country of registration | Czechia |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 64 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. VULKAN - Medical, a.s. was not found in either the U.S. or the Canadian register.