Vitrolife AB/Scandinavian Ivf Sciences AB
Country not established
- Devices
- 7
What Vitrolife AB/Scandinavian Ivf Sciences AB makes
The company manufactures cryopreservation and handling kits for human gametes and embryos, including media for freezing (Freeze-Kit 1), thawing (Thaw-Kit 1), and sperm washing (SpermRinse). It also supplies culture media for embryo development (G1.2, G2.2) and storage solutions (Gamete-100). Additional products include a sperm preparation system (HYBASE-1) and cryopreservation containers.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States and its products are listed in the FDA’s 510(k) registry.
Catalogue
Scandinavian Ivf Sciences Ab, Freeze-Kit 1 Ref K000623
510(k) 510(k)Scandinavian Ivf Sciences Ab, G1.2 Ref K000625
510(k) 510(k)Scandinavian Ivf Sciences Ab, Thaw-Kit 1 Ref K000618
510(k) 510(k)Scandinavian Ivf Sciences Ab, Gamete-100 Ref K000626
510(k) 510(k)Scandinavian Ivf Sciences Ab, Spermrinse -20/100 Ref K000621
510(k) 510(k)Scandinavian Ivf Sciences Ab, Hybase-1 Ref K000627
510(k) 510(k)Scandinavian Ivf Sciences Ab, G2.2 Ref K000619
510(k) 510(k)
Frequently asked questions
How many devices does Vitrolife AB/Scandinavian Ivf Sciences AB have in the registry?
The registry currently lists 7 devices for Vitrolife AB/Scandinavian Ivf Sciences AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vitrolife AB/Scandinavian Ivf Sciences AB's devices?
Among its 7 most recently registered devices, Vitrolife AB/Scandinavian Ivf Sciences AB has devices listed in FDA 510(k) (7 devices).
What risk classes do Vitrolife AB/Scandinavian Ivf Sciences AB's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Vitrolife AB/Scandinavian Ivf Sciences AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Vitrolife AB/Scandinavian Ivf Sciences AB in the registry?
The most recently registered devices listed for Vitrolife AB/Scandinavian Ivf Sciences AB include SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1, SCANDINAVIAN IVF SCIENCES AB, G1.2, SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1 and SCANDINAVIAN IVF SCIENCES AB, GAMETE-100.