Vitrolife A/S
DK-MF-000001892 · Denmark · Viby J
Vitrolife A/S is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 24 |
|---|
Among these devices, 5 are declared sterile, 19 active.
Devices declared under this manufacturer
- CulturePro
- ES server version 7
- EmbryoScope
- EmbryoScope 8
- EmbryoScope Flex
- EmbryoScope+
- EmbryoSlide
- EmbryoSlide Flex culture dish
- EmbryoSlide+
- EmbryoSlide+ ic8 dish
- EmbryoViewer
- KIDScore D5
Showing 12 of 24 declared devices.
Catalogue references include 16304, 16402, 16406, 16409, 16532, 16537.
European nomenclature codes declared: U080299, U080206.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Vitrolife A/S (DK) · FDA 3009107689 |
| Devices in EUDAMED | 24 |
| Country of registration | Denmark |
Device-level evidence
| Devices with a numeric GTIN | 24 |
|---|---|
| Found in the U.S. device database | 7 |
| Share | 29.2 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | VITROLIFE A/S |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| First licensed | 2013-07-17 |
Licence types: System (2).
Licensed under: EMBRYOSCOPE ES-D, EMBRYOSCOPE+ ES-P1.
North American profile: Both markets. Vitrolife A/S is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
10000473271-PA-NoMA-DNK | issued | 2027-06-27 |