Every classified device has a 3 Alphabet Code assigned by US FDA and from there you can get the classification of your device.
We support our clients in
Class 1 Device Listing
Class 2 510K Approvals (A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device)
Enter your contact information below and a member of our team will reach out to you shortly.
DKNSB Medical Device Consultants is backed by 20 years of experience with the aim to provide Technical and Regulatory Support to Medical Device Manufacturers from India and Overseas.
Objective: Hassle-Free Regulatory Approval for Indian Manufacturers, Foreign Manufacturers and Importers.