Phonak Brand
Roger Focus II-312 (velvet black)
1manufacturer
12catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Shangchuang Technology Service Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 23 |
Record
| Listed by | Sonova AG, Switzerland |
|---|---|
| FDA product code | LZI |
| Device type | Device, Assistive Listening |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3320 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-07-08 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 056-3006-P6 | In distribution | |
| 056-3005-P8 | In distribution | |
| 056-3006-P8 | In distribution | |
| 056-3006-T7 | In distribution | |
| 056-3006-M7 | In distribution | |
| 056-3006-Q3 | In distribution | |
| 056-3005-P6 | In distribution | |
| 056-3006-M6 | In distribution | |
| 056-3006-H0 | In distribution | |
| 056-3006-Q2 | In distribution | |
| 056-3006-T3 | In distribution | |
| 056-3006-M8 | In distribution |
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.