Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8020802

FEI Number

5711

Entity Name

SEDATELEC

City/State/Country

IRIGNY Rhone, FR

Establishment Address

CHEMIN DES MURIERS, IRIGNY Rhone F-69540, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SEDATELEC (Owner Number: 8020802)

Owner / Operator Contact Address

CHEMIN DES MURIERS, --, IRIGNY, FR-NOTA F-69540, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K101267

PMA Number

N/A

All Registered Proprietary Names

ASP Titanium ASP Gold ASP Classic ASP Multi Gold ASP Multi Classic ASP Multi Titanium PREMIO 10 moxa

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQX	Needle, Acupuncture, Single Use	General Hospital	Class 2	880.5580	2007-12-18
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2011-01-10

Official Correspondent

HOUSSEM BRAKNI

US Agent Details

Kevin Walls Business: Regulatory Insight, Inc. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

SEDATELEC

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 8020802. Last updated year: 2026. Please use registration number 8020802 when referencing this establishment in official correspondence.