Rexton

Rexton RCU SMART CONNECT B SET-US. Hearing aid accessory.

Registry build 21.09.26
29manufacturers in China registered for this device type
2,876catalogue 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.

Chinese manufacturers registered for FDA product code OSM
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

Regulatory record for Rexton
Listed by WS Audiology USA, Inc., United States
FDA product code OSM
Device type Hearing Aid, Air-Conduction With Wireless Technology, Prescription
Device class Class 2
Regulation 21 CFR 874.3305
Establishment Contract manufacturer, Manufacturer
Premarket notification Exempt
Record published 2016-05-04
Record revised 2023-02-08 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Over the counter Yes
Label carries serial number
Distribution end date 2025-11-01

Catalogue Numbers

Catalogue numbers for Rexton
Catalogue number Size Status
KIT BiCore C R-Li In distribution
Excellence 800 RIC A7 In distribution
HA EMERALD S 10 E1 BG In distribution
BiCore B-Li M Rugged 60 In distribution
BiCore B P 20 In distribution
BiCore R312 SDemo In distribution
KIT BiCore C R-Li In distribution
Reach B-Li HP 20 In distribution
C_ITE STERLING 40 6C ITC DIR,N4 In distribution
Excellence 400 RIC A7 In distribution
KIT BiCore C R-Li T In distribution
KIT M-Core R-Li 80 In distribution
KIT M-Core R-Li 80 In distribution
KIT BiCore C R-Li In distribution
KIT M-Core R-Li 80 In distribution
BiCore SR Demo In distribution
Reach R-Li T 40 In distribution
Reach B-Li P 20 In distribution
C_ITE STERLING 10 E1 ITC (N) In distribution
Reach Custom ITE 60 In distribution
Reach CROS R-Li In distribution
C_ITE STERLING 20 E1 CIC (T5) In distribution
Reach B-Li Rugged 80 In distribution
Reach B-Li P 30 In distribution
Reach Custom ITE 20 In distribution
KIT BiCore C R-Li In distribution
BiCore B M 30 In distribution
Reach R-Li T BC 80 In distribution
Reach B-Li P 80 In distribution
C_ITE STERLING 80 8C CIC In distribution
BiCore B P 30 In distribution
Reach B-Li P 60 In distribution
KIT BiCore C R-Li In distribution
Reach B-Li P 80 In distribution
KIT M-Core R-Li 80 In distribution
Reach R-Li T BC 80 In distribution
HA M-CORE R312 60/T DKC In distribution
Reach R-Li T 40 In distribution
KIT M-Core R-Li 80 In distribution
BiCore R-LI T 40 In distribution
Excellence 800 BTE A6 In distribution
BiCore RIC312 40 In distribution
KIT M-Core R-Li 80 In distribution
HA MOSAIC P 20 E1 GR In distribution
HA MOSAIC M 20 E1 GR In distribution
HA EMERALD S 30 E1 DGT In distribution
S_ITE INOX ITC 10 E1 L BG In distribution
HA MOSAIC M 20 E1 BRN In distribution
Reach B-Li HP 30 In distribution
Reach R-Li T 30 In distribution
M-CORE B-LI-HP 40 In distribution
HA M-CORE R312 SD/T GNT In distribution
KIT BiCore C R-Li In distribution
Sterling 10 E1 In distribution
BiCore R312 30 In distribution
KIT BiCore C R-Li In distribution
BiCore B HP 20 In distribution
Reach B-Li Rugged 40 In distribution
BiCore RIC312 80 In distribution
BiCore B HP 10 In distribution
M-CORE B-LI-M 20 In distribution
HA RX MOSAIC M 10 E1 DGT In distribution
M-CORE B-LI-P 60 In distribution
KIT M-Core R-Li 80 In distribution
HA MOSAIC P 60 6C BG In distribution
KIT BiCore C R-Li In distribution
Reach B-Li P 20 In distribution
KIT BiCore C R-Li T In distribution
M-CORE B-LI-M 80 In distribution
BiCore R-Li T 30 In distribution
BiCore R-Li 30 In distribution
Reach B-Li P 40 In distribution
KIT BiCore C R-Li T DEMO In distribution
HA MOSAIC HP 40 6C DBR In distribution
HA MOSAIC P 80 6C PRL In distribution
KIT BiCore C R-Li T In distribution
M-CORE B-LI-P 40 In distribution
M-CORE B-LI-M 40 In distribution
C_ITE STERLING 60 8C IIC In distribution
M-Core R312 20 with Tcoil In distribution
Reach B-Li HP 60 In distribution
KIT M-Core R-Li 80 In distribution
Reach B-Li HP 30 In distribution
M-CORE B-LI-HP 40 In distribution
M-CORE B-LI-P 30 In distribution
Reach B-Li Rugged 40 In distribution
M-Core R312 20 with Tcoil In distribution
KIT BiCore C R-Li In distribution
C_ITE STERLING 40 6C HS (T) In distribution
BiCore RIC312 40 In distribution
BiCore B HP 20 In distribution
KIT BiCore C R-Li T In distribution
Reach iX-CIC Li 30 In distribution
KIT BiCore C R-Li In distribution
Reach B-Li P 30 In distribution
HA MOSAIC HP 80 6C DBR In distribution
Reach CROS R-Li T BC In distribution
HA M-CORE R312 40/T BLK In distribution
KIT BiCore C R-Li In distribution
KIT BiCore C R-Li T In distribution
KIT BiCore C R-Li In distribution
Excellence 400 RIC A7 In distribution
M-Core B-Li-HP 80 In distribution
KIT BiCore C R-Li In distribution
BiCore RIC312 40 In distribution
KIT BiCore C R-Li In distribution
KIT BiCore C R-Li In distribution
BiCore R312 30 In distribution
KIT M-Core R-Li 80 In distribution
M-CORE B-LI-HP 40 In distribution
Reach R-Li T 20 In distribution
HA MOSAIC HP 30 E1 DGT In distribution
BiCore R-Li T 30 In distribution
BiCore B M 10 In distribution
HA MOSAIC S 30 E1 BRN- DGT In distribution
KIT BiCore C R-Li In distribution
Reach B-Li Rugged 80 In distribution
KIT BiCore C R-Li T In distribution
KIT BiCore C R-Li T In distribution
KIT M-Core R-Li 80 In distribution
BiCore R-LI T 80 In distribution
Reach R-Li T 30 In distribution
Reach iX-CIC Li 30 In distribution
S_ITE INOX CIC 10 E1 R BG In distribution
BiCore B M 20 In distribution
BiCore B HP 10 In distribution
Sterling 20 8C ITE In distribution
C_ITE STERLING 40 6C CIC (T5) In distribution
BiCore CROS R-LI In distribution
BiCore R-Li 40 In distribution
KIT BiCore C R-Li In distribution
Reach iX-CIC Li 20 In distribution
BiCore R-Li T 80 In distribution
KIT BiCore C R-Li In distribution
Reach B-Li Rugged 60 In distribution
BiCore R-LI T In distribution
BiCore B M 20 In distribution
Excellence 600 BTE A6 In distribution
KIT BiCore C R-Li In distribution
HA MOSAIC HP 30 E1 GR In distribution
Reach CROS R-Li In distribution
BiCore SR 60 In distribution
SET CROS RIC 8C GR In distribution
M-CORE B-LI-HP 60 In distribution
KIT BiCore C R-Li T In distribution
HA MOSAIC HP 20 E1 DBR In distribution
KIT M-Core R-Li 80 In distribution
M-CORE B-LI-HP 60 In distribution
BiCore R-Li 80 In distribution
KIT BiCore C R-Li T In distribution
BiCore R-Li 30 In distribution
BiCore B M 20 In distribution
KIT BiCore C R-Li In distribution
KIT BiCore C R-Li T In distribution
BiCore RIC312 80 In distribution
HA MOSAIC P 30 E1 SLV In distribution
M-CORE B-LI-HP 40 In distribution
Reach B-Li P 60 In distribution
Reach iX-CIC Li 60 In distribution
SET CROS LI RIC 8C SB In distribution
KIT BiCore C R-Li In distribution
Reach Custom ITE 80 In distribution
Reach iX-CIC Li 60 In distribution
IF CIC Travel Charger In distribution
KIT BiCore C R-Li T In distribution
KIT M-Core R-Li 80 In distribution
M-CORE B-LI-HP 80 In distribution
BiCore RIC312 80 In distribution
BiCore R312 20 In distribution
Reach B-Li HP 80 In distribution
BiCore B HP 30 In distribution
Reach B-Li HP 40 In distribution
KIT M-Core R-Li 80 In distribution
C_ITE STERLING 20 E1 HS DIR(N4) In distribution
KIT BiCore C R-Li DEMO In distribution
BiCore CROS SR In distribution
KIT M-Core R-Li 80 In distribution
HA EMERALD S 30 E1 BRN In distribution
HA EMERALD S 10 E1 BRN In distribution
BiCore B-Li M Rugged 60 In distribution
Excellence 400 RIC A7 In distribution
HA MOSAIC S 30 E1 DGT In distribution
KIT BiCore C R-Li T In distribution
M-CORE B-LI-P 30 In distribution
Kit BiCore C R-LI T In distribution
KIT M-Core R-Li 80 In distribution
HA MOSAIC P 40 6C BG In distribution
C_ITE STERLING30 E1 ITE DIR(O2) In distribution
KIT BiCore C R-Li In distribution
C_ITE STERLING 60 8C CIC In distribution
C_ITE ADORE ITE In distribution
C_ITE STERLING 10 E1 HS (T) In distribution
BiCore RIC312 60 In distribution
KIT BiCore C R-Li In distribution
M-Core IX-CIC 40 In distribution
BiCore R-LI 80 In distribution
Excellence 800 RIC A7 In distribution
BiCore R312 30 In distribution
BiCore R-Li T SDemo In distribution
BiCore B HP 20 In distribution
S_ITE CROS INOX 8C R MOC TRD In distribution
HA MOSAIC S 40 6C BG In distribution
C_ITE STERLING 30 E1 CIC (T) In distribution
BiCore R-Li 30 In distribution
KIT BiCore C R-Li In distribution
SET DEMO CROS RIC 8C BG In distribution
KIT BiCore C R-Li In distribution
KIT BiCore C R-Li T In distribution
C_ITE STERLING30 E1 ITE DIR(N4) In distribution
HA MOSAIC S 10 E1 DGT In distribution
M-Core RIC312 20 In distribution
Kit BiCore C R-LI In distribution
C_ITE STERLING 80 6C HS (T) In distribution
Reach B-Li HP 30 In distribution
M-Core R312 30 with Tcoil In distribution
M-CORE B-LI-M 30 In distribution
KIT BiCore C R-Li In distribution
C_ITE STERLING 20 E1 HS (N) In distribution
KIT BiCore C R-Li T In distribution
BiCore R-LI 80 In distribution
HA MOSAIC M 30 E1 SLV In distribution
KIT BiCore C R-Li T In distribution
KIT BiCore C R-Li T In distribution
KIT BiCore C R-Li T In distribution
M-CORE B-LI-M 80 In distribution
HA M-CORE R312 40/T DBR In distribution
KIT M-Core R-Li 80 In distribution
Reach R-Li T 30 In distribution
BiCore R312 20 In distribution
KIT BiCore C R-Li T In distribution
HA M-CORE R312 40 BLK In distribution
Reach B-Li P 60 In distribution
KIT M-Core R-Li 80 In distribution
KIT BiCore C R-Li DEMO In distribution
Reach R-Li T 80 In distribution
BiCore R-Li 20 In distribution
KIT BiCore C R-Li T In distribution
Reach B-Li P 40 In distribution
C_ITE STERLING 40 6C ITC (T) In distribution
HA MOSAIC M 30 E1 BG In distribution
HA MOSAIC S 30 E1 BG In distribution
HA M-CORE R312 80/T DKC In distribution
KIT BiCore C R-Li T In distribution
M-CORE B-LI-HP 80 In distribution
M-CORE B-LI-M 80 In distribution
KIT BiCore C R-Li T In distribution
BiCore R312 20 In distribution
BiCore B HP 10 In distribution
M-CORE B-LI-HP 20 In distribution
HA M-CORE R312 80 RGD In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA 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
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
Bernafon Bernafon, Inc. 1,154

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer