Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011697465

FEI Number

3011697465

Entity Name

VIVELL SAS

City/State/Country

Medellin Antioquia, CO

Establishment Address

calle 30A # 69 47, Belen Rosales, Medellin Antioquia 050030, CO

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

vivell SAS (Owner Number: 10093320)

Owner / Operator Contact Address

calle 30A # 69 47, Belen Rosales, Medellin, CO-ANT 050030, CO

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Fajate For Men FFM Fajate Delie

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDR	Binder, Medical, Therapeutic	General Hospital	Class 1	880.5160	2025-04-30

Official Correspondent

Claudia Pacheco

US Agent Details

Katherine Grullon Email: katy@distrivision.com Phone: (401) 7266162

Related Public Records

Same Entity

vivell SAS

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 3011697465. Last updated year: 2026. Please use registration number 3011697465 when referencing this establishment in official correspondence.