The US FDA has classified the Medical Devices as

• Class 1 devices
• Class 2 devices
• Class 3 devices

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

1. Facility Registration
2. Class 1 Device Listing
3. 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)
4. 21CFR820 Compliance
5. Training on FDA Audits

Please ask for Quotation