Unitron Brand
Moxi B-RS FLEX:TRIAL on-the-go Kit (platinum)
Who Else Makes It
Concentrated in Guangdong (17), Fujian (6), Jiangsu (3). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GN Resound China, Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| Xiamen Newsound Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| Huizhou Jinghao Medical Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 5 |
| Austar Hearing Science & Technology (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 5 |
| VTech Communications Ltd | Dongguan | Guangdong | Contract manufacturer | 5 |
| Xiamen Retone Hearing Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 5 |
| Hangzhou Acosound Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 4 |
| Minami Medical Technology (Guangdong) Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 4 |
| Sonova Hearing (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 3 |
| Shenzhen Yuezhongxing Technology Co., Ltd. | Huizhou | Guangdong | Repacker / relabeller | 10 |
| Hong YU Kang Technology (Guangdong) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Kangfu Medical Equipment Factory | Wenzhou | Zhejiang | Manufacturer | 6 |
Showing 12 of 29. All 29 manufacturers in China registered for Hearing Aid, Air-Conduction With Wireless Technology, Prescription
Record
| Listed by | Sonova AG, Switzerland |
|---|---|
| FDA product code | OSM |
| Device type | Hearing Aid, Air-Conduction With Wireless Technology, Prescription |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3305 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-05-16 |
| Record revised | 2023-11-03 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2023-05-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 051-5031-P6 | In distribution | |
| 050-6542-R844 | In distribution | |
| 050-6403-P474 | In distribution | |
| 050-6517-P465 | In distribution | |
| 050-6439-P474 | In distribution | |
| 051-5031-P744 | In distribution | |
| 050-6519-P665 | In distribution | |
| 050-6518-R865 | In distribution | |
| 050-6409-P474 | In distribution | |
| 050-6540-P744 | In distribution | |
| 051-5028-P6 | In distribution | |
| 050-6522-P644 | In distribution | |
| 050-6478-P644 | In distribution | |
| 050-6474-P644 | In distribution | |
| 050-6510-P665 | In distribution | |
| 050-6541-P6 | In distribution | |
| 050-6473-P744 | In distribution | |
| 050-6545-P644 | In distribution | |
| 050-6513-P465 | In distribution | |
| 051-5037-P744 | In distribution | |
| 050-6409-P774 | In distribution | |
| 050-6510-P765 | In distribution | |
| 050-6541-R844 | In distribution | |
| 075-5858-10065 | In distribution | |
| 050-6436-P674 | In distribution | |
| 050-6410-P774 | In distribution | |
| 050-6520-R844 | In distribution | |
| 050-6479-P644 | In distribution | |
| 051-5053-P8 | In distribution | |
| 051-5050-R8 | In distribution | |
| 050-6479-R8 | In distribution | |
| 050-6519-P4 | In distribution | |
| 050-6462-P474 | In distribution | |
| 050-6549-P6 | In distribution | |
| 063-6312-01 | In distribution | |
| 050-6463-R874 | In distribution | |
| 050-6543-R8 | In distribution | |
| 050-6519-R8 | In distribution | |
| 051-5050-P6 | In distribution | |
| 050-6540-R844 | In distribution | |
| 050-6553-R844 | In distribution | |
| 050-6518-P644 | In distribution | |
| 050-6513-P644 | In distribution | |
| 050-6520-P7 | In distribution | |
| 050-6542-P744 | In distribution | |
| 050-6474-P6 | In distribution | |
| 050-6477-R8 | In distribution | |
| 051-5025-R844 | In distribution | |
| 050-6511-P765 | In distribution | |
| 050-6514-P2 | In distribution | |
| 050-6479-P8 | In distribution | |
| 075-5856-11 | In distribution | |
| 050-6481-R844 | In distribution | |
| 050-6550-P6 | In distribution | |
| 050-6474-R8 | In distribution | |
| 050-6512-P465 | In distribution | |
| 051-5034-P6 | In distribution | |
| 050-6416-R874 | In distribution | |
| 050-6520-P765 | In distribution | |
| 051-5062-R844 | In distribution | |
| 050-6517-P7 | In distribution | |
| 050-6448-P774 | In distribution | |
| 050-6521-P7 | In distribution | |
| 050-6519-P744 | In distribution | |
| 050-6520-R865 | In distribution | |
| 051-5043-P644 | In distribution | |
| 050-6514-P4 | In distribution | |
| 050-6438-P474 | In distribution | |
| 051-5034-P644 | In distribution | |
| 050-6518-P665 | In distribution | |
| 050-6519-P2 | In distribution | |
| 050-6478-P6 | In distribution | |
| 050-6520-P6 | In distribution | |
| 050-6402-P474 | In distribution | |
| 050-6514-P465 | In distribution | |
| 050-6473-R8 | In distribution | |
| 050-6511-P8 | In distribution | |
| 075-5858-12065 | In distribution | |
| 050-6473-P6 | In distribution | |
| 050-6519-P7 | In distribution | |
| 075-5856-10 | In distribution | |
| 050-6513-P665 | In distribution | |
| 063-6315-01 | In distribution | |
| 050-6519-P6 | In distribution | |
| 075-5869-11 | In distribution | |
| 050-6549-P644 | In distribution | |
| 050-6471-P644 | In distribution | |
| 063-6333-01 | In distribution | |
| 050-6546-P6 | In distribution | |
| 050-6519-R865 | In distribution | |
| 050-6553-P744 | In distribution | |
| 051-5028-R8 | In distribution | |
| 050-6518-P4 | In distribution | |
| 058-5178-055 | In distribution | |
| 050-6470-P6 | In distribution | |
| 051-5065-R844 | In distribution | |
| 050-6549-R8 | In distribution | |
| 050-6517-P665 | In distribution | |
| 050-6519-P465 | In distribution | |
| 050-6547-P6 | In distribution | |
| 050-6442-P474 | In distribution | |
| 050-6510-P7 | In distribution | |
| 063-6336-01 | In distribution | |
| 050-6543-P644 | In distribution | |
| 050-6510-P744 | In distribution | |
| 063-6382-01 | In distribution | |
| 050-6481-P644 | In distribution | |
| 050-6512-R865 | In distribution | |
| 050-6514-P444 | In distribution | |
| 050-6545-P744 | In distribution | |
| 050-6518-R8 | In distribution | |
| 051-5059-P8 | In distribution | |
| 050-6438-R874 | In distribution | |
| 075-5865-11 | In distribution | |
| 075-5867-10 | In distribution | |
| 050-6414-P474 | In distribution | |
| 051-5053-R8 | In distribution | |
| 050-6475-P8 | In distribution | |
| 050-6407-P674 | In distribution | |
| 050-6547-P744 | In distribution | |
| 050-6516-P644 | In distribution | |
| 050-6520-P744 | In distribution | |
| 050-6511-P744 | In distribution | |
| 050-6544-R844 | In distribution | |
| 050-6442-P774 | In distribution | |
| 050-6415-P474 | In distribution | |
| 050-6483-P644 | In distribution | |
| 050-6514-P744 | In distribution | |
| 050-6404-P774 | In distribution | |
| 050-6522-P6 | In distribution | |
| 050-6407-R874 | In distribution | |
| 050-6510-P6 | In distribution | |
| 050-6404-R874 | In distribution | |
| 058-5180-055 | In distribution | |
| 051-5065-P744 | In distribution | |
| 050-6470-P8 | In distribution | |
| 050-6517-P644 | In distribution | |
| 050-6516-P744 | In distribution | |
| 051-5034-R844 | In distribution | |
| 050-6545-R8 | In distribution | |
| 050-6543-P8 | In distribution | |
| 050-6540-R8 | In distribution | |
| 050-6475-R844 | In distribution | |
| 050-6439-P674 | In distribution | |
| 050-6511-P644 | In distribution | |
| 050-6439-P774 | In distribution | |
| 050-6518-R844 | In distribution | |
| 050-6480-R844 | In distribution | |
| 050-6551-P644 | In distribution | |
| 050-6546-P8 | In distribution | |
| 050-6443-P474 | In distribution | |
| 050-6518-P6 | In distribution | |
| 050-6472-P644 | In distribution | |
| 050-6513-P4 | In distribution | |
| 051-5053-P6 | In distribution | |
| 050-6513-P444 | In distribution | |
| 051-5056-P644 | In distribution | |
| 050-6520-P444 | In distribution | |
| 051-5034-R8 | In distribution | |
| 050-6476-P6 | In distribution | |
| 051-5025-P8 | In distribution | |
| 051-5025-R8 | In distribution | |
| 050-6472-P8 | In distribution | |
| 050-6401-P474 | In distribution | |
| 050-6517-P6 | In distribution | |
| 050-6521-P4 | In distribution | |
| 051-5056-P8 | In distribution | |
| 050-6403-P674 | In distribution | |
| 050-6448-R874 | In distribution | |
| 050-6521-P8 | In distribution | |
| 050-6510-R8 | In distribution | |
| 050-6512-P7 | In distribution | |
| 051-5062-P6 | In distribution | |
| 050-6444-P474 | In distribution | |
| 050-6514-P644 | In distribution | |
| 050-6512-P2 | In distribution | |
| 050-6515-P665 | In distribution | |
| 050-6514-R865 | In distribution | |
| 050-6463-P674 | In distribution | |
| 050-6553-P644 | In distribution | |
| 050-6442-R874 | In distribution | |
| 051-5037-R844 | In distribution | |
| 050-6541-P644 | In distribution | |
| 050-6448-P474 | In distribution | |
| 051-5040-P644 | In distribution | |
| 050-6512-P6 | In distribution | |
| 050-6513-P7 | In distribution | |
| 050-6518-P765 | In distribution | |
| 050-6521-R865 | In distribution | |
| 050-6541-P744 | In distribution | |
| 050-6540-P6 | In distribution | |
| 050-6409-R874 | In distribution | |
| 051-5053-R844 | In distribution | |
| 063-6339-01 | In distribution | |
| 050-6544-P8 | In distribution | |
| 050-6514-P6 | In distribution | |
| 050-6461-P474 | In distribution | |
| 050-6548-P744 | In distribution | |
| 050-6409-P674 | In distribution | |
| 050-6476-P644 | In distribution | |
| 051-5068-P6 | In distribution | |
| 063-6306-01 | In distribution | |
| 050-6552-P644 | In distribution | |
| 050-6520-R8 | In distribution | |
| 050-6473-P8 | In distribution | |
| 050-6521-R8 | In distribution | |
| 051-5068-P644 | In distribution | |
| 050-6510-P444 | In distribution | |
| 050-6548-P6 | In distribution | |
| 050-6471-R844 | In distribution | |
| 050-6471-P744 | In distribution | |
| 051-5053-P744 | In distribution | |
| 050-6546-P644 | In distribution | |
| 075-5869-10 | In distribution | |
| 050-6477-P744 | In distribution | |
| 051-5028-P744 | In distribution | |
| 088-5016 | In distribution | |
| 051-5031-P644 | In distribution | |
| 050-6402-R874 | In distribution | |
| 050-6463-P774 | In distribution | |
| 050-6408-R874 | In distribution | |
| 050-6471-R8 | In distribution | |
| 050-6482-P644 | In distribution | |
| 050-6517-R8 | In distribution | |
| 050-6441-P474 | In distribution | |
| 050-6514-P665 | In distribution | |
| 050-6441-P774 | In distribution | |
| 063-6318-01 | In distribution | |
| 050-6513-R8 | In distribution | |
| 050-6518-P2 | In distribution | |
| 050-6404-P474 | In distribution | |
| 050-6518-P465 | In distribution | |
| 050-6470-R8 | In distribution | |
| 050-6540-P644 | In distribution | |
| 051-5056-P744 | In distribution | |
| 051-5025-P6 | In distribution | |
| 050-6437-P774 | In distribution | |
| 050-6472-P6 | In distribution | |
| 050-6476-P744 | In distribution | |
| 050-6549-P744 | In distribution | |
| 050-6415-P774 | In distribution | |
| 050-6550-P644 | In distribution | |
| 063-6303-01 | In distribution | |
| 050-6473-R844 | In distribution | |
| 075-5866-11 | In distribution | |
| 050-6517-R844 | In distribution | |
| 050-6518-P444 | In distribution | |
| 050-6544-P744 | In distribution | |
| 063-6384-01 | In distribution | |
| 050-6511-R8 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Widex | Widex A/S | 6,599 |
| GN ReSound | GN Hearing A/S | 5,200 |
| Oticon | Oticon A/S | 3,931 |
| GN Hearing | GN Hearing A/S | 3,076 |
| Signia | WS Audiology USA, Inc. | 2,980 |
| Rexton | WS Audiology USA, Inc. | 2,876 |
| Phonak | Phonak, Inc. | 2,406 |
| Beltone | GN Hearing A/S | 2,196 |
| Unitron | Unitron Hearing Division | 1,901 |
| Unitron | Unitron Hearing | 1,745 |
| HHM | Oticon A/S | 1,329 |
| Miracle-Ear | WS Audiology USA, Inc. | 1,211 |
Showing 12 of 619. All products under Hearing Aid, Air-Conduction With Wireless Technology, Prescription
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.