Orthoguard Sp. z o.o.
PL-MF-000050865 · Poland · Sokołów Podlaski
Orthoguard Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 41 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 41 |
|---|
Devices declared under this manufacturer
- Balkonik Statyczny STEP FIX
- Kula łokciowa Czarna AXIS ERGO
- Kula łokciowa Czerwona AXIS ERGO
- Kula łokciowa Niebieska AXIS ERGO
- Kula łokciowa Szara AXIS ERGO
- Laska inwalidzka Szara AXIS PURE
- Orteza kończyny dolnej OG-WK004 (M)
- Orteza stawu kolanowego OG-KN001 (2XL)
- Orteza stawu kolanowego OG-KN002 (3XL)
- Orteza stawu kolanowego OG-KN002 (XL)
- Podpórka Czterokołowa VIVA MOTION
- Taboret prysznicowy AQUA BENCH
Showing 12 of 41 declared devices.
Catalogue references include 2XL, OG-HY-AQU-BCH-UNI-UN, OG-HY-AQU-SPN-BLU-UN, OG-MO-AXI -ERG-BLK-UN, OG-MO-AXI -ERG-BLU-UN, OG-MO-AXI -ERG-GRY-UN.
European nomenclature codes declared: Y061209, Y06120601, Y12030601, Y091203, Y120399, Y120609.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 41 |
| 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 | 41 |
|---|---|
| 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. Orthoguard Sp. z o.o. was not found in either the U.S. or the Canadian register.