FDA device listing
Genie Medical BAHS 2023.1,Genie Medical BAHS 2024.2,Screwdriver HexaDrive,Sentio 1 Mini, CBE,Sentio 1 Mini, CNB,Sentio 1…
FDA device listing 1811903945 · DEMANT A/S
Key facts
| Proprietary names | Genie Medical BAHS 2023.1,Genie Medical BAHS 2024.2,Screwdriver HexaDrive,Sentio 1 Mini, CBE,Sentio 1 Mini, CNB,Sentio 1 Mini, DBL,Sentio 1 Mini, SIL,Sentio 1 Mini, STG,Sentio 1 Mini, TC,Sentio Position Marker, non-sterile,Sentio Ti Implant Kit,Spare Fixation Screws |
|---|---|
| Owner/operator | DEMANT A/S |
| Owner/operator number | 8010048 |
| Premarket submissions | K240614 |
| Product codes | PFO |
| Device names | PFO - Active Implantable Bone Conduction Hearing System |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.3340 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | Demant Operations Poland Sp. z o.o., ITSA Medical, Oticon Medical AB |
| Establishment registrations | 3007367732, 3009307953, 3032579106 |
| FEI numbers | 3007367732, 3009307953, 3032579106 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer, Contract Manufacturer, Contract Sterilizer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database