MEDICEM Technology s.r.o.
CZ-MF-000000928 · Czechia · Kamenne Zehrovice
MEDICEM Technology s.r.o. is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 12 |
|---|
Most frequent device types declared: Dilapan-S, Dilasoft.
Among these devices, 12 are declared sterile.
Devices declared under this manufacturer
- Dilapan-S
- Dilasoft
Catalogue references include DF355, DF455, DF465, DS355, DS455, DS465.
European nomenclature codes declared: U99.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Medicem Technology s.r.o (CZ) · FDA 3003994796 |
| Devices in EUDAMED | 12 |
| Country of registration | Czechia |
Device-level evidence
| Devices with a numeric GTIN | 12 |
|---|---|
| Found in the U.S. device database | 6 |
| Share | 50.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MEDICEM TECHNOLOGY S.R.O. |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| First licensed | 2006-07-20 |
Licence types: Device Family (2).
Licensed under: DILAPAN-S, THE HYGROSCOPIC CERVICAL DILATOR, DILASOFT.
North American profile: Both markets. MEDICEM Technology s.r.o. is registered in both the United States and Canada.