SIGVARIS SPÓŁKA AKCYJNA
PL-MF-000004824 · Poland · Warszawa
SIGVARIS SPÓŁKA AKCYJNA is registered in the European database on medical devices as a manufacturer, with 3 053 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 3 053 |
|---|
Most frequent device types declared: MOBILIS ManuPlusSupport Orteza nadgarstka i kciuka, PT 0302 Opaska elastyczna stawu skokowego, PT 0401 Rajstopy uciskowe CLASSIC CCL 2, PT 0406 Pończochy uciskowe CLASSIC CCL 1, PT 0407 Rajstopy uciskowe CLASSIC CCL 1.
Devices declared under this manufacturer
- MOBILIS ManuPlusSupport Thumb Wrist stabilizer, right, L
- PT 0302 Elastic ankle support, M
- PT 0401 Compression tights CLASSIC CCL 2, toe closed, short, beige, M
- PT 0403 Compression stockings CLASSIC CCL 2, grip top: dots, toe open,
- PT 0406 Compression stockings CLASSIC CCL 1, grip top: dots, toe close
- PT 0406 Compression stockings CLASSIC CCL 1, grip top: dots, toe open,
- PT 0407 Compression tights CLASSIC CCL 1, toe open, long, light beige,
- PT 0411 Maternity compression tights CLASSIC CCL 1, toe open, short, b
- PT 0414 Compression stocking with suspender belt CLASSIC CCL 2, right,
- PT 0431 Compression tights DELICATE CCL 1, toe open, short, beige, S P
- PT 0432 Compression stockings DELICATE CCL 1, toe closed, short, light
- PT 0461 Compression tights PREMIUM CCL 2, toe closed, long, beige, III
Showing 12 of 3 053 declared devices.
Catalogue references include 302M, 314548, 401K3BM, 407OD1BL, 414PODCXXXL, 432ZK1BS.
European nomenclature codes declared: M030405, Y060403, Y060699, Y060312.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 3 053 |
| 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 | 3 053 |
|---|---|
| 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. SIGVARIS SPÓŁKA AKCYJNA was not found in either the U.S. or the Canadian register.