Vitrolife Sweden AB
SE-MF-000002389 · Sweden · Göteborg
Vitrolife Sweden AB is registered in the European database on medical devices as a manufacturer, with 227 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 227 |
|---|
Among these devices, 226 are declared sterile.
Devices declared under this manufacturer
- Biopsy Pipette
- Centrifuge Tube 50 mL
- Cyst Puncture Needle with Stylet
- Follicle Aspiration Set, Double Lumen
- Follicle Aspiration Set, Single Lumen
- Hatching Pipette
- Holding Pipette
- ICSI Pipette
- Micro-droplet Culture Dish
- OVOIL
- Pasteur Pipette 1 mL
- Rapid-i Kit
Showing 12 of 227 declared devices.
Catalogue references include 14421, 15117, 15122, 15412, 15434, 15541.
European nomenclature codes declared: U0802030106, U0802030101, U08020201, U0802030105, U08020202, A019009.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | VITROLIFE SWEDEN AB (SE) · FDA 3003995932 |
| Devices in EUDAMED | 227 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 227 |
|---|---|
| Found in the U.S. device database | 213 |
| Share | 93.8 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | VITROLIFE SWEDEN AB |
What it holds in Canada
| Licences on record | 34 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 32 |
| Class 4 devices | 2 |
| First licensed | 2004-10-13 |
Licence types: Single Device (22), Device Family (9), Device Group Family (2), Device Group (1).
Licensed under: G-MOPS, G-RINSE, SPERMGRAD, SPERMRINSE, HSA-SOLUTION, ASP.
North American profile: Both markets. Vitrolife Sweden AB is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
10000500633-PA-NoMA-SVK | issued | 2027-09-06 |
10000500631-PA-NoMA-SVK | issued | 2027-09-05 |