Nidacon International AB
SE-MF-000001933 · Sweden · Mölndal
Nidacon International AB is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 14 |
|---|
Most frequent device types declared: NO-100, PS100-1000K, PS80-100, PS90-100, PSB-100.
Among these devices, 12 are declared sterile.
Devices declared under this manufacturer
- NidOil
- PureSperm 100
- PureSperm 40
- PureSperm 40/80
- PureSperm 80
- PureSperm 90
- PureSperm Buffer
- PureSperm Wash
- SpermCryoProtec
Showing 12 of 14 declared devices.
Catalogue references include NO-100, PS100-1000K, PS80-100, PS90-100, PSB-100, PSW-006.
European nomenclature codes declared: U08020502.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | NIDACON INTERNATIONAL AB (SE) · FDA 9616005 |
| Devices in EUDAMED | 14 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 14 |
|---|---|
| Found in the U.S. device database | 13 |
| Share | 92.9 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | NIDACON INTERNATIONAL AB |
What it holds in Canada
| Licences on record | 10 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 10 |
| First licensed | 2004-11-01 |
Licence types: Single Device (6), Device Group (2), Device Family (1), Test Kit (1).
Licensed under: PURESPERM, PURESPERM SPEEDIKIT, PURESPERM WASH, SPERM CRYOPROTEC, SPERMCATCH, PURESPERM 100.
North American profile: Both markets. Nidacon International AB is registered in both the United States and Canada.