Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017552081

FEI Number

3017552081

Entity Name

NEW WELLNESS CONCEPT SL

City/State/Country

Sevilla Andalusia, ES

Establishment Address

Avda. Republica Argentina 25, Sevilla Andalusia 41011, ES

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

New Wellness Concept SL (Owner Number: 10079895)

Owner / Operator Contact Address

Avda. Republica Argentina 25, Seville, ES-AN 41011, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MYHIXEL RING

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LKY	Device, External Penile Rigidity	Gastroenterology, Urology	Class 2	876.5020	2024-12-23

Official Correspondent

No official correspondent registered.

US Agent Details

Ryan Flynn Business: Global Import Agent LLC. Email: rf@primority.com Phone: (863) 6227900

Related Public Records

Same Entity

New Wellness Concept SL

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 3017552081. Last updated year: 2026. Please use registration number 3017552081 when referencing this establishment in official correspondence.