SpofaDental a.s.
CZ-MF-000000945 · Czechia · Jicin
SpofaDental a.s. is registered in the European database on medical devices as a manufacturer, with 37 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 37 |
|---|
Devices declared under this manufacturer
- Depural Neo
- Elastic Cromo
- F.I.T.T.
- Image
- Impression Compound
- Repin
- Stomaflex
- Tessex
- Tessex AL
- Ypeen
Showing 12 of 37 declared devices.
Catalogue references include 27416DX, 27419DX, 27426A, 27426DX, 27427DX, 27461A.
European nomenclature codes declared: Q01020101, Q01020199, Q010503, Q01020104, Q01020601, Q01010403.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SpofaDental a.s. (CZ) · FDA 3007743883 |
| Devices in EUDAMED | 37 |
| Country of registration | Czechia |
Device-level evidence
| Devices with a numeric GTIN | 37 |
|---|---|
| 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: United States only. SpofaDental a.s. is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
44911240240 | issued | 2031-05-10 |