Identity
- Trade Name
- Sentio FDA UDI
- Generic Name
- Implantable vibrator bone-conduction hearing implant system FDA UDI
- Device Name
- SENTIO 1 MINI, TC FDA UDI
- Model / Reference
- 205339 FDA UDI
- Description
- SENTIO 1 MINI, TC FDA UDI
Identifiers
- Catalog Number
- 205339 FDA UDI
- Primary DI / UDI-DI
- 05712149025466 FDA UDI
- FDA Product Code
- PFO FDA UDI
- GMDN Term
- Implantable vibrator bone-conduction hearing implant system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Implantable vibrator bone-conduction hearing implant system
Sentio by Oticon Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable vibrator bone-conduction hearing implant system.
- BCI Lifts (2 mm & 3 mm) — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class II
- BCI Lifts (1 mm) — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class II
- BCI Bone Conduction Implant Kit — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class II
- BCI Lifts (4 mm) — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class II
- BCI 602 Kit — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class II
- BCI 602 Lifts (1 mm) — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class II
- BCI Bone Conduction Implant Kit — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class II
- Sentio — Oticon Medical · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Oticon Medical
Sources (1)
- FDA UDI 3ab06c35-8232-4a93-89af-460fcea9938e 34 fields · synced May 30, 2026