Bernafon

CL100 Itcd, H L BE Celebrate 100

Registry build 21.09.26
11manufacturers in China registered for this device type
156catalogue numbers in this listing

Who Else Makes It

Concentrated in Fujian (7), Guangdong (3), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LRB
Manufacturer City Province Registered as Device types
Xiamen Newsound Technology Co., Ltd. Xiamen Fujian Contract manufacturer 7
Austar Hearing Science & Technology (Xiamen) Co., Ltd. Xiamen Fujian Contract manufacturer 5
Xiamen Retone Hearing Technology Co., Ltd. Xiamen Fujian Contract manufacturer 5
GN Resound China, Ltd. Xiamen Fujian Contract manufacturer 7
Xiamen Vienatone Medical Technology Co., Ltd. Xiamen Fujian Manufacturer 5
Jiangsu Betterlife Medical Co., Ltd. Jiangsu Jiangsu Manufacturer 4
Xiamen Melosound Technology Co., Ltd. Xiamen Fujian Contract manufacturer 4
Xiamen Realink Hearing Technology Co., Ltd. Xiamen Fujian Manufacturer 4
Shenzhen Byring Hearing Technology Co., Ltd. Shenzhen Guangdong Manufacturer 3
Shenzhen Zhongde Audio-Technical Co., Ltd. Shenzhen Guangdong Contract manufacturer 3
Zhongshan XIN Hongsheng Technology Co., Ltd. Zhongshan Guangdong Manufacturer 2

Record

Regulatory record for Bernafon
Listed by Bernafon, Inc., United States
FDA product code LRB
Device type Face Plate Hearing Aid
Device class Class 1
Regulation 21 CFR 874.3300
Premarket notification Exempt
Record published 2016-09-21
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 Bernafon
Catalogue number Size Status
153892 In distribution
108218 In distribution
149408 In distribution
186051 In distribution
170078 In distribution
140298 In distribution
123000 In distribution
107814 In distribution
108206 In distribution
105636 In distribution
186054 In distribution
108220 In distribution
132556 In distribution
116-20-401-10 In distribution
116-22-400-10 In distribution
116-21-810-10 In distribution
116-21-130-10 In distribution
116-20-101-10 In distribution
116-20-301-10 In distribution
116-21-611-10 In distribution
151488 In distribution
170586 In distribution
149395 In distribution
116-21-100-10 In distribution
127852 In distribution
156447 In distribution
107812 In distribution
108221 In distribution
116-20-511-10 In distribution
127814 In distribution
149393 In distribution
116-21-511-10 In distribution
116-21-111-10 In distribution
116-22-300-10 In distribution
108213 In distribution
149398 In distribution
149401 In distribution
127851 In distribution
116-21-101-10 In distribution
149400 In distribution
116-21-300-10 In distribution
153891 In distribution
124691 In distribution
116-21-311-10 In distribution
127815 In distribution
149388 In distribution
140300 In distribution
116-20-500-10 In distribution
108217 In distribution
116-20-510-10 In distribution
116-20-410-10 In distribution
191987 In distribution
107807 In distribution
108216 In distribution
116-22-200-10 In distribution
153888 In distribution
140299 In distribution
156446 In distribution
116-21-620-10 In distribution
107815 In distribution
116-21-310-10 In distribution
116-21-411-10 In distribution
107802 In distribution
116-22-410-10 In distribution
116-22-500-10 In distribution
132558 In distribution
116-21-401-10 In distribution
116-21-610-10 In distribution
132563 In distribution
170071 In distribution
185895 In distribution
149397 In distribution
140297 In distribution
149410 In distribution
116-22-700-10 In distribution
122553 In distribution
116-21-500-10 In distribution
116-20-600-10 In distribution
170584 In distribution
116-20-110-10 In distribution
151491 In distribution
107810 In distribution
116-20-100-10 In distribution
170589 In distribution
170069 In distribution
149407 In distribution
170585 In distribution
107813 In distribution
116-20-501-10 In distribution
132561 In distribution
140292 In distribution
156449 In distribution
116-20-311-10 In distribution
116-21-400-10 In distribution
122551 In distribution
149387 In distribution
127850 In distribution
107811 In distribution
116-22-600-10 In distribution
116-20-611-10 In distribution
116-22-510-10 In distribution
151490 In distribution
149394 In distribution
116-20-810-10 In distribution
149409 In distribution
185999 In distribution
108219 In distribution
108208 In distribution
127849 In distribution
116-21-510-10 In distribution
108207 In distribution
116-21-601-10 In distribution
170587 In distribution
116-22-210-10 In distribution
140293 In distribution
116-20-411-10 In distribution
105431 In distribution
132559 In distribution
116-22-110-10 In distribution
149396 In distribution
116-20-111-10 In distribution
108215 In distribution
116-21-120-10 In distribution
108205 In distribution
156448 In distribution
191990 In distribution
186002 In distribution
116-20-400-10 In distribution
108222 In distribution
122552 In distribution
116-22-310-10 In distribution
116-21-501-10 In distribution
140294 In distribution
185892 In distribution
192033 In distribution
132557 In distribution
116-20-300-10 In distribution
132560 In distribution
127848 In distribution
151492 In distribution
116-21-410-10 In distribution
192036 In distribution
126148 In distribution
116-20-601-10 In distribution
149399 In distribution
132562 In distribution
116-21-110-10 In distribution
116-20-610-10 In distribution
170588 In distribution
108214 In distribution
116-21-301-10 In distribution
116-20-310-10 In distribution
116-21-630-10 In distribution
116-21-600-10 In distribution
116-22-100-10 In distribution
122550 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Oticon Oticon A/S 472
GN ReSound GN Hearing A/S 134
Beltone GN Hearing A/S 82
Sonic Sonic Innovations, Inc. 66
Audina Audina Hearing Instruments, Inc. 63
Philips Sbo Hearing A/S 24
Oticon Sbo Hearing A/S 11
Bernafon Sbo Hearing A/S 8
Austar Austar Hearing Science & Technology (Xiamen) Co., Ltd. men) Co., Ltd. 6
Birdsong Sbo Hearing A/S 6
Retone Xiamen Retone Hearing Technology Co., Ltd. 5
Agxo Sbo Hearing A/S 4

Showing 12 of 15. All products under Face Plate Hearing Aid

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