Ophthalmic Device FDA Registration
(Non-active Class I Medical Devices) Ophthalmic devices are designed to prevent and potential eye da...
CE Marking of Medical Thermometer
Different types of Thermometers, Classification and Conformity assessment and routes for MDR CE Mark...
Substantial Equivalence
Substantial Equivalence is the demonstration that a new device, compared to a predicate device for t...
Covid 19 Emergency use Devices and FDA Registration and Listing Information
# Product Nature Product Code Approval 1 Surgical Face Mask Sterile / Non-Sterile FXX ...
Abbreviated 510k & Guidance
The medical devices for which the FDA 510k or premarket notification is required from the US FDA bef...