Information for US Customers:
Our dedicated US website is now available at us.sudoscan.com. Feel free to visit it for local product information and support.
Impeto Medical SAS
2 Rue Maurice Hartmann,
92130 Issy Les Moulineaux
France
SUDOSCAN Inc.
8525 Gibbs Dr. Suite 304
San Diego, CA 92123
International: +33 (0)7 87 20 32 03
Sudoscan Inc: 858-450-2800
To report a suspected serious incident or for any safety and medical vigilance inquiries regarding our devices, please contact our Quality & Regulatory Affairs department directly at vigilance-impeto@withings.com.
Sudoscan is a class IIa Medical device, Manufactured by Impeto Medical, indicated for early identification and follow-up of peripheral autonomic neuropathies.
For professional use only, read instructions before use. This medical device is a regulated health product which bears, under this regulation, the CE mark
Promotional Communication. The medical devices SUDOSCAN & EZSCAN are regulated health products under the CE certification, Class IIa, according to the European Medical Device directive – SGS Belgium, notified body 1639. The test allows screening and monitoring of peripheral autonomic neuropathies. It can be performed in diabetic patients or in patients suffering from neurological diseases involving small fibers damage. As with any diagnostic test, its results must be interpreted in a global context including the clinic and other examinations performed. Please read the user manual instructions carefully. Contact our office for more information. Last update: 2021/01/12
