Sage Biopharma
Country not established
- Devices
- 6
What Sage Biopharma makes
Sage Biopharma manufactures media and solutions for assisted reproductive technology, including formulations for gamete preparation, embryo culture, and cryopreservation (e.g., propanediol, glycerol, and sucrose-based freezing media). Their portfolio also includes hyaluronidase enzymes for sperm processing and serum protein substitutes for culture media. Additionally, they provide large-scale water for tissue culture applications in laboratory settings.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. These devices are listed in the FDA’s 510(k) database. Sage Biopharma operates from the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Media For Gamete Preparation And Embryo Culture Ref K002836
Regimes: 510(k) Registry: 510(k)Hyaluronidase, 80 U/Ml Ref K991393
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Serum Protein Substitute Ref K003734
Regimes: 510(k) Registry: 510(k)Water For Tissue Culture, Models 500 L & 1.5 L Ref K991396
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sage Biopharma have in the registry?
The registry currently lists 6 devices for Sage Biopharma. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sage Biopharma's devices?
Among its 6 most recently registered devices, Sage Biopharma has devices listed in FDA 510(k) (6 devices).
What risk classes do Sage Biopharma's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Sage Biopharma's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sage Biopharma in the registry?
The most recently registered devices listed for Sage Biopharma include PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED, MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE, HYALURONIDASE, 80 U/ML and 1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI.