Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002807108

FEI Number

3002807108

Entity Name

Sanofi S.r.l.

City/State/Country

ANAGNI Frosinone, IT

Establishment Address

LOCALITA VALCANELLO, ANAGNI Frosinone 03012, IT

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SANOFI-AVENTIS U.S. LLC (Owner Number: 9054794)

Owner / Operator Contact Address

100 Morris Street, --, Morristown, NJ 07960, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sculptra and Sculptra Aesthetic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LMH	Implant, Dermal, For Aesthetic Use	Unknown	Class 3	N/A	2008-01-16

Official Correspondent

Kathleen Holdren

US Agent Details

Allison Steele Business: Sanofi Email: allison.steele@sanofi.com Phone: (908) 6720250

Related Public Records

Same Entity

SANOFI-AVENTIS U.S. LLC

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 3002807108. Last updated year: 2026. Please use registration number 3002807108 when referencing this establishment in official correspondence.