Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014166044

FEI Number

3014166044

Entity Name

X6 INNOVATIONS

City/State/Country

Paris Ile-de-France, FR

Establishment Address

128 rue La Boetie, Paris Ile-de-France 75008, FR

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

X6 Innovations (Owner Number: 10056375)

Owner / Operator Contact Address

15 rue du Louvre, X6 Innovations (PERIFIT), bat 4A, Etage 2, Paris, FR-IDF 75001, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221476

PMA Number

N/A

All Registered Proprietary Names

Perifit Pump Perifit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2024-02-26
HIR	Perineometer	Obstetrics/Gynecology	Class 2	884.1425	2023-02-14

Official Correspondent

Robin Reynaud

US Agent Details

Stephan Toupin Business: Dawa Medical LLC Email: customerservices@dawamedical.com Phone: (305) 5999373

Related Public Records

Same Entity

X6 Innovations

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K190465	Hygeia II Medical Group, Inc.	Evolve Breast Pump	2019-10-18
K021739	Limerick, Inc.	LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002	2003-01-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014166044. Last updated year: 2026. Please use registration number 3014166044 when referencing this establishment in official correspondence.