Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008496197

FEI Number

3008496197

Entity Name

IMPETO MEDICAL

City/State/Country

Issy-les-Moulineaux Ile-de-France, FR

Establishment Address

2 Rue Maurice Hartmann, Issy-les-Moulineaux Ile-de-France 92130, FR

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Withings (France) (Owner Number: 10035674)

Owner / Operator Contact Address

2 rue Maurice Hartmann, Issy-les-Moulineaux, FR-NOTA 92130, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K100233

PMA Number

N/A

All Registered Proprietary Names

SUDOSCAN2 SUDOSCAN S SUDOSCAN SmartSKAN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GZO	Device, Galvanic Skin Response Measurement	Neurology	Class 2	882.1540	2022-11-30

Official Correspondent

No official correspondent registered.

US Agent Details

Michael Daniel Business: Daniel & Daniel Consulting, LLC Email: madaniel@clinregconsult.com Phone: (415) 4070223

Related Public Records

Same Entity

Withings (France)

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013689228	Withings HK Limited	Hong-Kong, HK
3008820594	Withings	Issy-les-Moulineaux Ile-de-France, FR

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008496197. Last updated year: 2026. Please use registration number 3008496197 when referencing this establishment in official correspondence.