Samba 2 Remote (Android)
Mobile Application Remote Control
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (2), Shanghai (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| IN-Tech Electronics Ltd | Dongguan | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. |
|---|---|
| FDA product code | PFO |
| Device type | Active Implantable Bone Conduction Hearing System |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3340 |
| Record published | 2020-09-08 |
| Record revised | 2023-11-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 52047 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cochlear | Cochlear Ltd. | 7 |
| Sentio | Oticon Medical AB | 7 |
| Cochlear® Osia® 3 Sound Processor Magnet strength 4M | Cochlear Ltd. | 5 |
| Cochlear® Osia® 3(I) Sound Processor Magnet strength 4(I) | Cochlear Ltd. | 5 |
| Cochlear® Osia® Smart App | Cochlear Ltd. | 2 |
| Cochlear® Osia® Fitting Software 3 | Cochlear Ltd. | 2 |
| Symfit 8.0 Download | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. | 2 |
| BCI Bone Conduction Implant Kit | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. | 2 |
| Cochlear® Osia® 3 Sound Processor Cover Mint | Cochlear Ltd. | 1 |
| Remote Control | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. | 1 |
| Cochlear® Osia® 3(I) Sound Processor | Cochlear Ltd. | 1 |
| Samba 2 BB AP Unit, left | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. | 1 |
Showing 12 of 69. All products under Active Implantable Bone Conduction Hearing System
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.