Onsen Sp. z o.o.
PL-MF-000037523 · Poland · Toruń
Onsen Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 82 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 82 |
|---|
Most frequent device types declared: 120cm x 200cm + Purotex, 140x200, 160cm x 200cm, 180cm x 200cm, 180cm x 200cm + Purotex.
Devices declared under this manufacturer
- Anatomical office chair Seiza
- Anti-decubitus bed cover Airflow Mesh 3D
- Antyalergiczna poszewka na poduszkę Dani
- Antyalergiczna poszwa na kołdrę Dani
- Biurko ergonomiczne Seiwa
- Mizu - specjalistyczny, oddychający i wodoodporny ochraniacz na matera
- Orthopedic Pillow Asana
- Orthopedic Pillow Enso
- Orthopedic Pillow Hiro
- Orthopedic Pillow Yoko
- Orthopedic foam mattress Osaka Air
- Ortopedyczny materac hybrydowy Osaka Grid
Showing 12 of 82 declared devices.
Catalogue references include 5905123515019, 5905123515408, 5905123515453, 5905868656695, 5905868656909, 5905868656947.
European nomenclature codes declared: V080702, V080302, Y0999, V08068002,V080702, T030502, Y1899.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 82 |
| Country of registration | Poland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 82 |
|---|---|
| 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. Onsen Sp. z o.o. was not found in either the U.S. or the Canadian register.