Newsound
142 catalogue numbers from LUX18 L(Primo R401 L), listed by Xiamen New Sound Technology Co., Ltd., under Hearing Aid, Air-Conduction, Prescription. 45 manufacturers in China are registered for this product code.
45manufacturers in China registered for this device type
142catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (27), Fujian (9), Jiangsu (4). 10 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 |
| Guangdong Southvo Medical Technology Co., Ltd. | Qingyuan | Guangdong | Contract manufacturer | 6 |
| Huizhou Jinghao Medical Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 5 |
| Austar Hearing Science & Technology (Xiamen) Co., Ltd. | Xiamen | Fujian | 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 |
| Zhongshan Great-Ears Electronic Technology Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 3 |
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
Showing 12 of 45. All 45 manufacturers in China registered for Hearing Aid, Air-Conduction, Prescription
Record
| Listed by | Xiamen New Sound Technology Co., Ltd. |
|---|---|
| FDA product code | ESD |
| Device type | Hearing Aid, Air-Conduction, Prescription |
| Device class | Class 1 |
| Regulation | 21 CFR 874.3300 |
| Premarket notification | Exempt |
| Record published | 2020-12-31 |
| Record revised | 2021-03-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2024-01-19 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| LUX18 L(Primo R401 L) | In distribution | ||
| Neosonic Qt | In distribution | ||
| Supertone I ITC | In distribution | ||
| Tweak Lite | In distribution | ||
| HCGO Beige | 2 | In distribution | |
| Neosonic MX-RIC | 2 | In distribution | |
| Primo E401 | 2 | In distribution | |
| HC 206 Grey | In distribution | ||
| VAN PRO 209 | In distribution | ||
| EU1021 | 2 | In distribution | |
| Rocker 200 | In distribution | ||
| ReFocus | In distribution | ||
| LUX 13 | 2 | In distribution | |
| EU1061 | In distribution | ||
| Poco M201 | 2 | In distribution | |
| HCR3 Grey | In distribution | ||
| Medley RC600 | In distribution | ||
| Helix | 2 | In distribution | |
| POCO Z101 | 2 | In distribution | |
| Realtone I ITE HD | In distribution | ||
| Van Pro 201 | In distribution | ||
| VIVE 20 | 2 | In distribution | |
| Rocker 800 | In distribution | ||
| RV4 | In distribution | ||
| Clarity10 | In distribution | ||
| Aria 800 | In distribution | ||
| Huisheng ITC | In distribution | ||
| HD Pro-V6 | In distribution | ||
| ARIA 206 R Pearl Gray | In distribution | ||
| Otofonix Encore Grey | In distribution | ||
| EU2010 | In distribution | ||
| RV4B | In distribution | ||
| POCO R101 L | In distribution | ||
| Puretone | In distribution | ||
| Ulaif | In distribution | ||
| Asana pro 400 | In distribution | ||
| Bee III 101 | In distribution | ||
| Huisheng CIC | In distribution | ||
| Asana pro 600 | In distribution | ||
| Class D | In distribution | ||
| TREO | In distribution | ||
| Primo R401 | 2 | In distribution | |
| SOUNDWEAR PRIMO U600 | In distribution | ||
| Poco Z401 | 2 | In distribution | |
| HA-302-4 Beige | 2 | In distribution | |
| Lucid30 | 2 | In distribution | |
| Primo R401 R | In distribution | ||
| Supertone I ITE | In distribution | ||
| Asana pro 200 | In distribution | ||
| Huisheng ITE | In distribution | ||
| SOUNDWEAR ROCEKR 202 | In distribution | ||
| DX400 | In distribution | ||
| LUX 12 L | In distribution | ||
| MAXear | In distribution | ||
| HA-302-4 Grey | 2 | In distribution | |
| TactEar 801 | 2 | In distribution | |
| Wing 8 CIC WP | In distribution | ||
| Pro 20 | 2 | In distribution | |
| Eartiva 500 P | In distribution | ||
| Van Plus 200 | In distribution | ||
| SAP40T | In distribution | ||
| Realtone | In distribution | ||
| Wing 8 ITC WP | In distribution | ||
| Neosonic MX | 2 | In distribution | |
| HCZ3 Beige | In distribution | ||
| Realtone I ITC | In distribution | ||
| VAN PLUS 800 | In distribution | ||
| SOUNDWEAR VIVO108 | In distribution | ||
| Bee 100 | In distribution | ||
| Van Pro 200 | In distribution | ||
| Rocker 400 | In distribution | ||
| Neosonice NW10 | In distribution | ||
| POCO R101 R | In distribution | ||
| VIVO 206 | In distribution | ||
| Van Pro 400 | In distribution | ||
| ER81N | In distribution | ||
| BW51 | In distribution | ||
| Bee III 200 | In distribution | ||
| HC 206 Beige | In distribution | ||
| Simply Tweak | In distribution | ||
| EU1080P | In distribution | ||
| LUX 10 | 2 | In distribution | |
| ARIA 206 L Pearl Gray | In distribution | ||
| HC X Beige | In distribution | ||
| Supertone I CIC | In distribution | ||
| HC X Grey | In distribution | ||
| Realtone I CIC HD | In distribution | ||
| Primo P200 | 2 | In distribution | |
| HC X Taupe | In distribution | ||
| Van 610 | In distribution | ||
| ROCKER 206D | In distribution | ||
| Realtone I ITE | In distribution | ||
| Legato 209 Beige | In distribution | ||
| Otofonix Encore Beige | In distribution | ||
| POCO Z101 | 2 | In distribution | |
| LUX18 R(Primo R401 R) | In distribution | ||
| LUX14 | 2 | In distribution | |
| Eartiva 500 | In distribution | ||
| Legato 209 Brown | In distribution | ||
| Primo S401 | 2 | In distribution | |
| Rocker 600 | In distribution | ||
| Van 401 | In distribution | ||
| VIVO 201 | In distribution | ||
| HA-802 Beige | 2 | In distribution | |
| Bee III 800 | In distribution | ||
| Rocker 602 | In distribution | ||
| HC64 | In distribution | ||
| EUBW21 | In distribution | ||
| Van 810 | In distribution | ||
| LX201 Silver | In distribution | ||
| Poco M401 | 2 | In distribution | |
| LUX 12 R | In distribution | ||
| Realtone I ITC HD | In distribution | ||
| Primo R401 L | In distribution | ||
| Aria 810 | In distribution | ||
| HCR3 Beige | In distribution | ||
| HC 206 Taupe | In distribution | ||
| HCRD Beige | 2 | In distribution | |
| Aria 200 | In distribution | ||
| Van Pro 800 | In distribution | ||
| Classic-RIC02 | 2 | In distribution | |
| Encore | 2 | In distribution | |
| MA41T | In distribution | ||
| HCZ3 Taupe | In distribution | ||
| EX2 | 2 | In distribution | |
| DX800 | In distribution | ||
| Aria 206 | In distribution | ||
| LX201 Beige | In distribution | ||
| Van 210 | In distribution | ||
| VAN PLUS 400 | In distribution | ||
| Wing | In distribution | ||
| ZIV 209 | In distribution | ||
| New TI 100 | In distribution | ||
| Supertone | In distribution | ||
| Neosonic EZ | In distribution | ||
| VIVO PRO 102 | In distribution | ||
| Realtone I CIC | In distribution | ||
| Nano Sigma Beige | 2 | In distribution | |
| VIVO 202 | 2 | In distribution | |
| Bee III 400 | In distribution | ||
| EU1080 | In distribution | ||
| Primo S201 | 2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Audio Service | WS Audiology USA, Inc. | 1,148 |
| Phonak | Phonak, Inc. | 610 |
| GN ReSound | GN Hearing A/S | 510 |
| Rexton | WS Audiology USA, Inc. | 363 |
| GN Hearing | GN Hearing A/S | 329 |
| Beltone | GN Hearing A/S | 313 |
| Siemens | WS Audiology USA, Inc. | 301 |
| Unitron | Unitron Hearing | 278 |
| Widex | Widex A/S | 177 |
| Tianle | Zhongshan Tianle Hearing Technology Co., Ltd. | 146 |
| Audina | Audina Hearing Instruments, Inc. | 144 |
| Biopor® AB | Dreve Otoplastik GmbH | 133 |
Showing 12 of 347. All products under Hearing Aid, Air-Conduction, 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.