L I N E T spol. s r.o.
CZ-MF-000009320 · Czechia · Slaný
L I N E T spol. s r.o. is registered in the European database on medical devices as a manufacturer, with 650 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 650 |
|---|
Among these devices, 47 are declared with a measuring function.
Devices declared under this manufacturer
- Eleganza 1
- Eleganza 2
- Eleganza 4 With scales
- Essenza 300
- Gracie
- HybriMatt 100
- HybriMatt 200
- Image 3 B
- Pasivní matrace EffectaCare 20 P, 137 x
- Pasivní matrace EffectaCare 20, 200x90x1
- Sella
- Sprint 100 Without scales
Showing 12 of 650 declared devices.
Catalogue references include 1EZ30000-4594, 1EZ30000-5477, 1EZ30000-5649, 1EZ30010-1818, 1GE412055-3663, 1GTP5746-184.
European nomenclature codes declared: V08060101, V080701, V080702, V08050101, V08060105, V08060199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | LINET spol. s r.o. (CZ) · FDA 3008058231 |
| Devices in EUDAMED | 650 |
| Country of registration | Czechia |
Device-level evidence
| Devices with a numeric GTIN | 650 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | LINET SPOL. S.R.O. |
What it holds in Canada
| Licences on record | 6 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 6 |
| First licensed | 2012-09-18 |
Licence types: Single Device (3), System (3).
Licensed under: MULTICARE, PROTEVO, OPTICARE, OPTICARE X, MULTICARE X, HYBRIMATT.
North American profile: Both markets. L I N E T spol. s r.o. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1031322-1 | supplemented | 2029-09-15 |