Pharma-Medica of Scandinavia, Ltd.
Country not established
- Devices
- 2
What Pharma-Medica of Scandinavia, Ltd. makes
Pharma-Medica of Scandinavia, Ltd. manufactures the Cariescreen-SM, a diagnostic device for detecting dental caries in children, and the URI-DIP, a rapid test for identifying respiratory infections caused by viruses or bacteria.
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
Cariescreen - Sm Ref K852987
Regimes: 510(k) Registry: 510(k)Uri-Dip (R) Ref K800626
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pharma-Medica of Scandinavia, Ltd. have in the registry?
The registry currently lists 2 devices for Pharma-Medica of Scandinavia, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pharma-Medica of Scandinavia, Ltd.'s devices?
Among its 2 most recently registered devices, Pharma-Medica of Scandinavia, Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Pharma-Medica of Scandinavia, Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Pharma-Medica of Scandinavia, Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Pharma-Medica of Scandinavia, Ltd. in the registry?
The most recently registered devices listed for Pharma-Medica of Scandinavia, Ltd. include CARIESCREEN - SM and URI-DIP (R).