Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018188559

FEI Number

3018188559

Entity Name

ECAREYOU INNOVATION S.L.

City/State/Country

Madrid Madrid (Province), ES

Establishment Address

Manuel Pombo Angulo, 28, 3rd - 4th Floor, Madrid Madrid (Province) 28050, ES

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ecareyou Innovation S.L. (Owner Number: 10080336)

Owner / Operator Contact Address

Manuel Pombo Angulo, 28, planta 3-4, Madrid, ES-MD 28050, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ENNA CYCLE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HHE	Cup, Menstrual	Obstetrics/Gynecology	Class 2	884.5400	2021-02-01

Official Correspondent

Alba Ruiz Castellano

US Agent Details

Scott Bednar Business: QA/RA CONSULTING GROUP, INC. Email: sbednar@qaraconsultinggroup.com Phone: (412) 4188066

Related Public Records

Same Entity

Ecareyou Innovation S.L.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018188559. Last updated year: 2026. Please use registration number 3018188559 when referencing this establishment in official correspondence.