Reveal

G30, Mrite 312 2.4G NFM PB C090 Reveal

Registry build 21.09.26
29manufacturers in China registered for this device type
82catalogue 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 Reveal
Listed by Oticon A/S, Denmark
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 2017-05-31
Record revised 2020-10-06 (version 3)

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Label carries serial number
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Reveal
Catalogue number Size Status
174986 In distribution
193504 In distribution
174981 In distribution
177294 In distribution
193399 In distribution
177293 In distribution
193575 In distribution
176130 In distribution
174997 In distribution
177305 In distribution
174979 In distribution
174996 In distribution
177297 In distribution
193580 In distribution
174994 In distribution
193574 In distribution
193394 In distribution
177308 In distribution
174983 In distribution
177298 In distribution
177302 In distribution
176134 In distribution
176131 In distribution
177316 In distribution
177301 In distribution
174995 In distribution
193572 In distribution
193395 In distribution
176133 In distribution
177296 In distribution
174989 In distribution
176136 In distribution
174984 In distribution
174991 In distribution
193502 In distribution
174993 In distribution
177315 In distribution
176089 In distribution
176132 In distribution
174978 In distribution
193400 In distribution
193391 In distribution
193581 In distribution
177313 In distribution
193505 In distribution
193393 In distribution
176088 In distribution
193401 In distribution
177317 In distribution
193573 In distribution
174987 In distribution
176086 In distribution
176085 In distribution
177299 In distribution
193396 In distribution
193509 In distribution
174977 In distribution
193392 In distribution
177309 In distribution
193386 In distribution
177300 In distribution
176091 In distribution
177314 In distribution
174980 In distribution
176084 In distribution
174992 In distribution
193385 In distribution
193403 In distribution
176137 In distribution
176090 In distribution
176135 In distribution
177311 In distribution
193384 In distribution
176087 In distribution
177307 In distribution
193579 In distribution
174985 In distribution
174982 In distribution
174990 In distribution
174988 In distribution
177295 In distribution
177303 In distribution

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
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.

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