Clinifax Industries, Ltd.
Country not established
- Devices
- 2
What Clinifax Industries, Ltd. makes
Clinifax Industries, Ltd. manufactures the BIOSCAN E12, a portable electrocardiogram (ECG) device for cardiac monitoring, and the TILL-U=TEST, a urine analysis strip reader for point-of-care diagnostics.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Bioscan E12 Ref K781421
Regimes: 510(k) Registry: 510(k)Till-U=test Ref K780109
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Clinifax Industries, Ltd. have in the registry?
The registry currently lists 2 devices for Clinifax Industries, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Clinifax Industries, Ltd.'s devices?
Among its 2 most recently registered devices, Clinifax Industries, Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Clinifax Industries, Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Clinifax Industries, Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Clinifax Industries, Ltd. in the registry?
The most recently registered devices listed for Clinifax Industries, Ltd. include BIOSCAN E12 and TILL-U=TEST.