Ursatec GmbH
DE-MF-000005353 · Germany · Tholey
Ursatec GmbH is registered in the European database on medical devices as a manufacturer, with 31 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 31 |
|---|
Most frequent device types declared: HNST01, HSNS01, ISNS01, ISNSD01, ISNSE01.
Among these devices, 1 are declared sterile.
Devices declared under this manufacturer
- 3K Pump NSP 100 mg
- AP3 Rachenpumpe 190 mg
- Cinuforce Neusspray forte + eucalyptus
- Hypertonic Saline Nasal Spray + 2% Dexpanthenol
- Hypertonic Saline Nasal Spray + Eucalyptus + Menthol Aroma
- Isotonic Nasal Spray with 2% Dexpanthenol + Aloe Vera Aroma
- Isotonic saline nasal spray
- Kruidvat Natures Neusspray Verstopte Neus
- Nasal Drops with 4% Sea Salt
- Nasal Drops with Sea Salt + Dexpanthenol
- Nasal Spray with Sea Salt + Dexpanthenol
- Nazamér med aloe vera aroma
Showing 12 of 31 declared devices.
Catalogue references include 3K Pump NSP 100 mg, 60005601UA, 6102123, 6494216, 6601018, 6601020.
European nomenclature codes declared: Q030103, A99.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | URSATEC GMBH (DE) · FDA 3015789003 |
| Devices in EUDAMED | 31 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 3 |
|---|---|
| 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. Ursatec GmbH is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ECM23MDR002 | issued | 2028-08-01 |