Wellspect HealthCare
SE-MF-000026271 · Sweden · Mölndal
Wellspect HealthCare is registered in the European database on medical devices as a manufacturer, with 395 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 395 |
|---|
Among these devices, 241 are declared sterile, 36 active.
Devices declared under this manufacturer
- LoFric Elle
- LoFric Insti-Cath
- LoFric Origo
- LoFric Sense
- Navina Catheter Set Regular
- Navina Mini Extension Set
- Navina Mini Refill Set
- Navina Mini Start Set
- Navina Smart Control Unit
- Navina Smart System Cone
- Navina™ Classic System Regular
- Navina™ Classic System Regular Refill
Showing 12 of 395 declared devices.
Catalogue references include 4160820, 4191030, 44012, 6894096, 6900565, 6900630.
European nomenclature codes declared: U01010501, G020301, G020199, U01010601.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Wellspect Healthcare (SE) · FDA 3009632672 |
| Devices in EUDAMED | 395 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 395 |
|---|---|
| Found in the U.S. device database | 97 |
| Share | 24.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | WELLSPECT HEALTHCARE |
What it holds in Canada
| Licences on record | 3 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 3 |
| First licensed | 2010-07-13 |
Licence types: Device Family (3).
Licensed under: LOFRIC NON-PVC URINARY CATHETER, LOFRIC DILA-CATH PVC-FREE, LOFRIC ELLE.
North American profile: Both markets. Wellspect HealthCare is registered in both the United States and Canada.