Zencera, Inc.
South KoreaFDA 510(k) applicant, unverified
- Devices
- 1
What Zencera, Inc. makes
Zencera, Inc. manufactures the ZIROX, a medical device designed for use in surgical procedures, specifically for reducing the risk of infection by eliminating bacteria and spores on surgical instruments and surfaces through hydrogen peroxide vapor sterilization.
The ZIROX is classified as a Class II device under FDA regulations and has been cleared via the 510(k) pathway. The company is based in the United States.
Catalogue
Zirox Ref K092630
510(k) 510(k)
Frequently asked questions
How many devices does Zencera, Inc. have in the registry?
The registry currently lists 1 device for Zencera, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Zencera, Inc.'s devices?
Among its 1 most recently registered device, Zencera, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Zencera, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Zencera, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Zencera, Inc. in the registry?
The most recently registered devices listed for Zencera, Inc. include ZIROX.