Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032579106

FEI Number

3032579106

Entity Name

ITSA Medical

City/State/Country

Vallauris Alpes-Maritimes, FR

Establishment Address

2720 Chemin St Bernard, Vallauris Alpes-Maritimes 06220, FR

Establishment Type(s)

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

Owner / Operator

DEMANT A/S (Owner Number: 8010048)

Owner / Operator Contact Address

KONGEBAKKEN 9, --, SMORUM, DK-NOTA DK-2765, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sentio 1 Mini, DBL Spare Fixation Screws Sentio Ti Implant Kit Sentio 1 Mini, CBE Sentio 1 Mini, SIL Sentio 1 Mini, STG Sentio 1 Mini, TC Genie Medical BAHS 2024.2 Sentio 1 Mini, CNB Genie Medical BAHS 2023.1 Sentio Position Marker, non-sterile Screwdriver HexaDrive

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PFO	Active Implantable Bone Conduction Hearing System	Ear, Nose, Throat	Class 2	874.3340	2024-07-11

Official Correspondent

No official correspondent registered.

US Agent Details

Laura Dixon Business: OTICON MEDICAL LLC Email: ladi@oticonmedical.com Phone: (760) 9082393

Related Public Records

Same Entity

DEMANT A/S

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3017441596	Demant Operations, S.a. De C.v.	Tijuana Baja California, MX
2240713	OTICON, INC.	SOMERSET, NJ, US
3002504821	MAICO Diagnostics GmbH	Berlin, DE
3005465494	Oticon A/S	Smorum Hovedstaden, DK
3007367732	Oticon Medical AB	Askim Vastra Gotaland, SE

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3005900820	COCHLEAR AMERICAS	Lone Tree, CO, US
3014579188	Cochlear Americas Warehouse	Centennial, CO, US
9613646	Cochlear Limited - Brisbane	Newstead Queensland, AU
3013177549	Cochlear Malaysia Sdn Bhd	Kuala Lumpur Kuala Lumpur, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032579106. Last updated year: 2026. Please use registration number 3032579106 when referencing this establishment in official correspondence.