K-Systems, Kivex Biotec, Ltd.
DenmarkFDA 510(k) applicant, unverified
- Devices
- 1
What K-Systems, Kivex Biotec, Ltd. makes
K-Systems, Kivex Biotec Ltd. manufactures culture bag sealers and disposable culture bags, including the CBS-1 and CB-01 models, designed for sterile biological sample processing and containment.
These products are regulated as Class II devices under FDA 510(k) clearance requirements and are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
- 510(k) 510(k)
Frequently asked questions
How many devices does K-Systems, Kivex Biotec, Ltd. have in the registry?
The registry currently lists 1 device for K-Systems, Kivex Biotec, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list K-Systems, Kivex Biotec, Ltd.'s devices?
Among its 1 most recently registered device, K-Systems, Kivex Biotec, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do K-Systems, Kivex Biotec, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for K-Systems, Kivex Biotec, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from K-Systems, Kivex Biotec, Ltd. in the registry?
The most recently registered devices listed for K-Systems, Kivex Biotec, Ltd. include K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01.