Electone

Electone HA ELECTONE FIGARO 4 SP BG Hearing Aid

Registry build 21.09.26
45manufacturers in China registered for this device type
25catalogue 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.

Chinese manufacturers registered for FDA product code ESD
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

Regulatory record for Electone
Listed by WS Audiology USA, Inc., United States
FDA product code ESD
Device type Hearing Aid, Air-Conduction, Prescription
Device class Class 1
Regulation 21 CFR 874.3300
Establishment Contract manufacturer, Manufacturer
Premarket notification Exempt
Record published 2016-05-02
Record revised 2023-02-08 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries serial number
Distribution end date 2020-11-30

Catalogue Numbers

Catalogue numbers for Electone
Catalogue number Size Status
HA EL FIGARO 4 OPEN BG Withdrawn
HA ALL SOUNDS BT BG Withdrawn
HA EL TANGO 3 P+ BG Withdrawn
HA EL EL 111 BG Withdrawn
HA ELECTONE FIGARO 4 SP BG Withdrawn
HA GENNUS PP BG Withdrawn
HA GENNUS PPL BG Withdrawn
HA GENESIS BG Withdrawn
HA EL FIGARO 8 P BG Withdrawn
HA ELECTONE TANGO 3 S+ BG Withdrawn
HA BTE EL FIGARO 8 S GR Withdrawn
HA LCIF 2SP BG Withdrawn
HA GENNUS BG Withdrawn
HA ELECTONE TANGO 2 S BG Withdrawn
HA EL FIGARO 4 P BG Withdrawn
HA GENESIS PLUS BG Withdrawn
HA GENESIS POWER BG Withdrawn
HA ELECTONE TANGO 2 SP BG Withdrawn
HA GENNUS AGC PP BG Withdrawn
HA EL TANGO PRO P BG Withdrawn
HA EL TANGO 2 P BG Withdrawn
HA ELECTONE TANGO 3 SP+ BG Withdrawn
HA ELECTONE TANGO PRO S BG Withdrawn
HA EL TANGO PRO SP BG Withdrawn
HA EL FIGARO 8 S BG Withdrawn

Same Product Code

Other products under the same FDA 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
Newsound Xiamen New Sound Technology Co., Ltd. 142

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.

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