Calyx Medical Sp. z o.o.
PL-MF-000038787 · Poland · Wrocław
Calyx Medical Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 8 |
|---|
Most frequent device types declared: SUR019, SUR020, SUR021, URO 053, URO 054.
Among these devices, 8 are declared sterile.
Devices declared under this manufacturer
- Agitator
- Dual Action Pump (Foot Variant)
- Dual Action Pump - Hand Variant
- Sealing Connector (S-Piece)
- Sealing Connector (T-Piece)
- Sealing Connector (Y-Piece)
- Syphon Fr 11/13 L 35cm
- Syphon Fr 11/13 L 45cm
Catalogue references include SUR019, SUR020, SUR021, URO 053, URO 054, URO 057.
European nomenclature codes declared: U090199, A03010202, Z12019007, Z12099099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | CALYX MEDICAL Sp. Z.O.O. (PL) · FDA 3030450856 |
| Devices in EUDAMED | 8 |
| Country of registration | Poland |
Device-level evidence
| Devices with a numeric GTIN | 8 |
|---|---|
| Found in the U.S. device database | 5 |
| Share | 62.5 % |
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: United States only. Calyx Medical Sp. z o.o. is registered in the United States but was not found in the Canadian register.