Cosmonde, a.s.
CZ-MF-000029535 · Czechia · Brno
Cosmonde, a.s. is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 9 |
|---|
Devices declared under this manufacturer
- Coolex Lubrikační gel na vodné bázi bez příchutě Natural
- Coolex Lubrikační gel na vodné bázi s příchutí Banán
- Coolex Lubrikační gel na vodné bázi s příchutí Jahoda
- Coolex Lubrikační gel na vodné bázi s příchutí Limeta
- Coolex Lubrikační gel na vodné bázi s příchutí Meloun
- Lubrikační gel na vodné bázi Vanilka
Catalogue references include CM007A-BL, Z1000, Z1001, Z1002, Z1003, Z1004.
European nomenclature codes declared: M9002.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 9 |
| Country of registration | Czechia |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 9 |
|---|---|
| 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. Cosmonde, a.s. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2025-MDR/QS-030/A | issued | 2030-05-13 |
2025-MDR/QS-029/A | issued | 2030-05-13 |