AccuQuest

AQ CO1 B 105, 2.4G NFM DPB Sabe/Msil Demo Accuq

Registry build 21.09.26
4manufacturers in China registered for this device type
23catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (3), Fujian (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KLW
Manufacturer City Province Registered as Device types
GN Resound China, Ltd. Xiamen Fujian Contract manufacturer 7
Sonova Hearing (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 3
Jiangsu Betterlife Medical Co., Ltd. Jiangsu Jiangsu Manufacturer 4
Starkey (Suzhou) Hearing Technology Co., Ltd. Guoxiang, Wuzhong District, Suzhou Jiangsu Manufacturer 3

Record

Regulatory record for AccuQuest
Listed by Bernafon, Inc., United States
FDA product code KLW
Device type Masker, Tinnitus
Device class Class 2
Regulation 21 CFR 874.3400
Record published 2018-08-20
Record revised 2020-10-06 (version 2)

Specifications

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

Catalogue Numbers

Catalogue numbers for AccuQuest
Catalogue number Size Status
192800 In distribution
192789 In distribution
192774 In distribution
192785 In distribution
192787 In distribution
192777 In distribution
192791 In distribution
192953 In distribution
192784 In distribution
192790 In distribution
192775 In distribution
192778 In distribution
192958 In distribution
192793 In distribution
192796 In distribution
192795 In distribution
192783 In distribution
192797 In distribution
192798 In distribution
192779 In distribution
192955 In distribution
192954 In distribution
192782 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Oticon Sbo Hearing A/S 570
Starkey Starkey Laboratories, Inc. 449
Phonak Sonova AG 448
Oticon Oticon A/S 353
Nuear Starkey Laboratories, Inc. 336
Audibel Starkey Laboratories, Inc. 318
Unitron Unitron Hearing Division 292
Audigy Starkey Laboratories, Inc. 284
Microtech Starkey Laboratories, Inc. 284
audifon Audifon – Gmbh & Co.kg 277
Philips Sbo Hearing A/S 270
Agxo Sbo Hearing A/S 260

Showing 12 of 86. All products under Masker, Tinnitus

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