ASTAR spółka z ograniczoną odpowiedzialnością
PL-MF-000010564 · Poland · Bielsko-Biała
ASTAR spółka z ograniczoną odpowiedzialnością is registered in the European database on medical devices as a manufacturer, with 48 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 32 |
|---|---|
| Class IIb | 16 |
Most frequent device types declared: 100A, 101A, 200A, 201A, 300A, 301A, 500I, 501I, 600C, 601C.
Among these devices, 30 are declared active.
Devices declared under this manufacturer
- Elastic Velcro strap 60x9 cm for attaching electrodes
- Multifunctional unit PhysioGo 301A
- Multifunctional unit PhysioGo 500I
- Multifunctional unit PhysioGo 501I
- Multifunctional unit PhysioGo 700I
- Multifunctional unit PhysioGo 701I
- PhysioGo.Lite Electro
- PhysioMG 825
- Reusable electrotherapy and electrostimulation electrodes 6x6cm
- Stainless steel point electrode - 15 mm diameter
- Stainless steel point electrode - 20 mm diameter
- Stainless steel point electrode - 6 mm diameter
Showing 12 of 48 declared devices.
Catalogue references include A-AE-AST-EL6060RV2, A-AE-AST-ELPT20V3, A-AE-AST-PR60X9CA, A-AE-AST-PW10X10, A-UC-AST-PHG500I, A-UC-AST-PHG501I.
European nomenclature codes declared: Z12062885, Z120602, Z120615, Z120601, Z120606, Z120610.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 48 |
| 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 | 48 |
|---|---|
| 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. ASTAR spółka z ograniczoną odpowiedzialnością was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1962094-1 | supplemented | 2028-08-01 |