Canwest Medictex, Inc.
CanadaFDA applicant, unverified
- Devices
- 2
What Canwest Medictex, Inc. makes
Canwest Medictex, Inc. manufactures urine pregnancy test devices, including the CANWEST OVU-BLUE for ovulation detection and the CANWEST-PREGBLUE for detecting pregnancy hormones in urine samples.
These products are regulated under FDA Class I and Class II classifications, with authorisation records maintained in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Canwest Ovu-Blue Ref K862055
Regimes: 510(k) Registry: 510(k)Canwest-Pregblue Ref K854989
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Canwest Medictex, Inc. have in the registry?
The registry currently lists 2 devices for Canwest Medictex, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Canwest Medictex, Inc.'s devices?
Among its 2 most recently registered devices, Canwest Medictex, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Canwest Medictex, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Canwest Medictex, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Canwest Medictex, Inc. in the registry?
The most recently registered devices listed for Canwest Medictex, Inc. include CANWEST OVU-BLUE and CANWEST-PREGBLUE.