# ITSA Medical

FEI: 3032579106
Status: Active
Establishment types: Sterilize Medical Device for Another Party (Contract Sterilizer); Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner/operator: DEMANT A/S (#8010048)

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

Mandatory US Agent: OTICON MEDICAL LLC

## Products

Total registered: 1
Top product codes: PFO
Regulation §: 874.3340

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

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223032579106%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3032579106