Oratio B.V.
NetherlandsFDA applicant, unverified
- Devices
- 1
What Oratio B.V. makes
Oratio B.V. manufactures the CYRTINA System, a medical device designed for [specific clinical application or function—if not provided, omit or clarify if this is a placeholder]. The system is intended for [brief, functional use, e.g., 'assisting in cardiac rhythm management' or 'implantable neurostimulation'] without further detail.
The CYRTINA System is classified as a Class II device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Cyrtina System Ref K063842
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Oratio B.V. have in the registry?
The registry currently lists 1 device for Oratio B.V.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Oratio B.V.'s devices?
Among its 1 most recently registered device, Oratio B.V. has devices listed in FDA 510(k) (1 device).
What risk classes do Oratio B.V.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Oratio B.V.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Oratio B.V. in the registry?
The most recently registered devices listed for Oratio B.V. include CYRTINA SYSTEM.