Ultrafem, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Ultrafem, Inc. makes
Ultrafem, Inc. manufactures vaginal barrier contraceptive devices, including the INSTEAD and SOFTCUP™, which are designed for single-use protection against sexually transmitted infections and unintended pregnancy.
These products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
Instead, Softcup Ref K971303
Regimes: 510(k) Registry: 510(k)Softcup(Tm):2 Ref K920792
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ultrafem, Inc. have in the registry?
The registry currently lists 2 devices for Ultrafem, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ultrafem, Inc.'s devices?
Among its 2 most recently registered devices, Ultrafem, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Ultrafem, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ultrafem, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ultrafem, Inc. in the registry?
The most recently registered devices listed for Ultrafem, Inc. include INSTEAD, SOFTCUP and SOFTCUP(TM):2.