Bayer Pharma AG
Country not established FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Bayer Pharma AG makes
Bayer Pharma AG manufactures the Essure System, a permanent birth control device designed for intrauterine placement to provide long-term contraception.
The Essure System is classified as a Class III medical device in the US and is listed under the FDA’s Premarket Approval (PMA) pathway.
Catalogue
Essure System Ref P020014
PMA PMA
FDA establishments
- Bayer Pharma, AG Berlin · DE FEI 3002808086
Frequently asked questions
How many devices does Bayer Pharma AG have in the registry?
The registry currently lists 1 device for Bayer Pharma AG. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bayer Pharma AG's devices?
Among its 1 most recently registered device, Bayer Pharma AG has devices listed in FDA PMA (1 device).
What risk classes do Bayer Pharma AG's devices fall under?
Among its 1 most recently registered device, the classes recorded for Bayer Pharma AG's devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from Bayer Pharma AG in the registry?
The most recently registered devices listed for Bayer Pharma AG include ESSURE SYSTEM.
Which FDA establishments are linked to Bayer Pharma AG?
1 FDA establishment is linked to Bayer Pharma AG in the registry; they are listed on the company page.