Check-Points Health B.V.
NetherlandsFDA applicant, unverified
- Devices
- 2
What Check-Points Health B.V. makes
Check-Points Health B.V. manufactures the BD MAX Check-Points CPO, a diagnostic system designed for detecting and identifying bacterial pathogens in bloodstream infections, including *Staphylococcus aureus* and *Enterococcus* species.
The BD MAX Check-Points CPO is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
- Registry: GUDID
BD MAX Check-Points CPO Ref K190613
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 409613986
Frequently asked questions
How many devices does Check-Points Health B.V. have in the registry?
The registry currently lists 2 devices for Check-Points Health B.V.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Check-Points Health B.V.'s devices?
Among its 2 most recently registered devices, Check-Points Health B.V. has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Check-Points Health B.V.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Check-Points Health B.V.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Check-Points Health B.V. in the registry?
The most recently registered devices listed for Check-Points Health B.V. include BD MAX Check-Points CPO 278102 and BD MAX Check-Points CPO.