Auxogyn, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 4
What Auxogyn, Inc. makes
Auxogyn, Inc. manufactures in vitro fertilization (IVF) laboratory devices, including the EEVA System and its variants (EEVA 2.0, EEVA Dish with 12 Microwells, and the EEVA Petri Dish). These products are designed for embryo culture and assessment in assisted reproductive technology settings.
The company’s portfolio is classified under FDA’s Class II medical devices and is authorised via the 510(k) clearance process. These devices are listed in the FDA’s 510(k) registry, and the company is headquartered in the United States.
Catalogue
Eeva System Ref K142147
510(k) 510(k)Eeva 2.0 Ref DEN120015
De Novo 510(k)Eeva Dish (With 12 Microwells) Ref K141663
510(k) 510(k)Eevatm Petri Dish Ref K103028
510(k) 510(k)
Frequently asked questions
How many devices does Auxogyn, Inc. have in the registry?
The registry currently lists 4 devices for Auxogyn, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Auxogyn, Inc.'s devices?
Among its 4 most recently registered devices, Auxogyn, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Auxogyn, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Auxogyn, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Auxogyn, Inc. in the registry?
The most recently registered devices listed for Auxogyn, Inc. include EEVA SYSTEM, EEVA 2.0, EEVA DISH (WITH 12 MICROWELLS) and EEVATM PETRI DISH.