Simex Medical, Inc.
Country not established
- Devices
- 1
What Simex Medical, Inc. makes
Simex Medical, Inc. manufactures modified versions of the Davidstrip HCG, a diagnostic device used for detecting human chorionic gonadotropin (hCG) in urine samples, typically for pregnancy testing.
The company’s portfolio is regulated under FDA’s Class II device classification and is listed via the 510(k) premarket notification process. The devices are based in the United States.
Catalogue
Modification Of: Davidstrip Hcg Ref K991067
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Simex Medical, Inc. have in the registry?
The registry currently lists 1 device for Simex Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Simex Medical, Inc.'s devices?
Among its 1 most recently registered device, Simex Medical, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Simex Medical, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Simex Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Simex Medical, Inc. in the registry?
The most recently registered devices listed for Simex Medical, Inc. include MODIFICATION OF: DAVIDSTRIP HCG.