Biuro Handlowe Kinesis Andrzej Boruta
PL-MF-000018445 · Poland · Iwonicz-Zdrój
Biuro Handlowe Kinesis Andrzej Boruta is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 28 |
|---|
Most frequent device types declared: AQUANESIS E/A, AQUANESIS E/M, AQUANESIS H, AQUANESIS P, CROSS.
Among these devices, 22 are declared active.
Devices declared under this manufacturer
- KRD
- Rotor KRG
- Schody do nauki chodzenia DynamicRehaStairs
- Stół do manualnego drenażu limfatycznego PROFI L Plus
- Stół rehabilitacyjny PERFECT II
- Stół rehabilitacyjny PERFECT III
- Stół rehabilitacyjny PRO 2
- Stół rehabilitacyjny PRO 3
- Stół rehabilitacyjny PRO 3 PLUS
- Stół rehabilitacyjny PRO 7
- Stół rehabilitacyjny PROFI 2 Plus
- Stół rehabilitacyjny PROFI 3 F Plus
Showing 12 of 28 declared devices.
Catalogue references include AQUANESIS E/M, AQUANESIS H, KRD, PRO 2, PROFI 3 Plus, PROFI 4 Plus.
European nomenclature codes declared: Z120602, V9099, Y0504, Y050201.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 28 |
| 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 | 28 |
|---|---|
| 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. Biuro Handlowe Kinesis Andrzej Boruta was not found in either the U.S. or the Canadian register.