Newsound
42 catalogue numbers from POCO SA801 L, listed by Xiamen New Sound Technology Co., Ltd., under Hearing Aid, Air-Conduction With Wireless Technology, Prescription. 29 manufacturers in China are registered for this product code.
29manufacturers in China registered for this device type
42catalogue numbers in this listing
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 | Xiamen New Sound Technology Co., Ltd. |
|---|---|
| FDA product code | OSM |
| Device type | Hearing Aid, Air-Conduction With Wireless Technology, Prescription |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3305 |
| Premarket notification | Exempt |
| Record published | 2020-12-31 |
| Record revised | 2020-10-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| POCO SA801 L | In distribution | ||
| Primo RA801 L | In distribution | ||
| Nano-SIGMA-Plus-B | 2 | In distribution | |
| Primo RA | In distribution | ||
| EARSPOKE | In distribution | ||
| Groove | 2 | In distribution | |
| Forte MA201 | In distribution | ||
| HCEQ | In distribution | ||
| Poco X406 | 2 | In distribution | |
| Nexus HD | 2 | In distribution | |
| SOUNDWEAR BW20 | In distribution | ||
| BT808R | In distribution | ||
| POCO X401 | 2 | In distribution | |
| SOUNDWEAR ULITE2000 L White | In distribution | ||
| IRIS10S | 2 | In distribution | |
| Otofonix Sona Beige | 2 | In distribution | |
| LUX 16A | 2 | In distribution | |
| BT402G | In distribution | ||
| Poco XA601 | 2 | In distribution | |
| IRIS 20 L | In distribution | ||
| Primo MA401 | 2 | In distribution | |
| Poco X403 | 2 | In distribution | |
| HA-900 | 2 | In distribution | |
| Primo SA401 | 2 | In distribution | |
| HearIQ ITC | 2 | In distribution | |
| Poco MU803 | 2 | In distribution | |
| POCO SA801 R | In distribution | ||
| Neosonic SF | In distribution | ||
| EON | 2 | In distribution | |
| Forte SA201 | 2 | In distribution | |
| IRIS 20R | In distribution | ||
| HearIQ 4 | 2 | In distribution | |
| Primo RA801 | 2 | In distribution | |
| Nano Sigma Silver | 2 | In distribution | |
| POCO ZA401 | 2 | In distribution | |
| Poco X405 | 2 | In distribution | |
| SOUNDWEAR ULITE2000 R White | In distribution | ||
| Primo RA801 R | In distribution | ||
| Primo DR6491 | 2 | In distribution | |
| EA40 | 2 | In distribution | |
| Poco X808 | 2 | In distribution | |
| Forte MA801 | In distribution |
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.