BioSonic

UC150 Cleaner Unit USA Plug Type A - No Heater

Registry build 21.09.26
48manufacturers in China registered for this device type
49catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (26), Zhejiang (7), Jiangsu (5). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FLG
Manufacturer City Province Registered as Device types
Shenzhen Heearly Technology Co., Ltd. Bao An District, Shenzhen Guangdong Contract manufacturer 13
Foshan Nanhai Plus Medical Co Ltd Foshan Guangdong Contract manufacturer 12
Xiamen Atyou Health Technology Co., Ltd. Xiamen Fujian Contract manufacturer 2
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Tribest Dental Products Co Ltd Yangzhong Jiangsu Contract manufacturer 58
Dongguan Wanjin Industrial Co., Ltd. Dongguang Guangdong Remanufacturer 41
Lakong Medical Devices Co., Ltd. Dongguan Guangdong Remanufacturer 39
Ningbo Just Soon Industrial Limited Ningbo Zhejiang Repacker / relabeller 36
Jinyuan Medical Equipment(Tianjin)Co., Ltd. Tianjin Tianjin Contract manufacturer 27
Yangzhou Fartley Medical Instrument Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 24
Zhengzhou Huaer Electro-Optics Technology Co., Ltd. Zhengzhou Henan Contract manufacturer 21

Showing 12 of 48. All 48 manufacturers in China registered for Cleaner, Ultrasonic, Medical Instrument

Record

Regulatory record for BioSonic
Listed by Coltene/Whaledent Gmbh & Co. KG, Germany
FDA product code FLG
Device type Cleaner, Ultrasonic, Medical Instrument
Device class Class 1
Regulation 21 CFR 880.6150
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
Premarket notification Exempt
Record published 2019-02-11
Record revised 2023-09-18 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Over the counter Yes
Label carries lot or batch number, expiry date, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for BioSonic
Catalogue number Size Per pack Status
UC125B115 In distribution
UC50DB230CE In distribution
60022040 In distribution
60040388 In distribution
UC300B115 In distribution
60022045 In distribution
60040390S In distribution
60021989 In distribution
UC30 In distribution
UC34 In distribution
UC155XD In distribution
UC42 In distribution
UC53 In distribution
UC38 In distribution
UC330 In distribution
60022042 8 In distribution
60022046 In distribution
60022044 In distribution
60040389S In distribution
60040393 In distribution
UC300230CE In distribution
UC300RB115 In distribution
60022047 In distribution
UC50DB230UK In distribution
UC315115 In distribution
60035062 In distribution
60021987 In distribution
600220410 In distribution
UC325 In distribution
UC39 In distribution
UC311 In distribution
UC335 2 In distribution
60040397 In distribution
UC32 In distribution
60021988 In distribution
60021990 In distribution
60040392 In distribution
UC125LCD In distribution
UC96 In distribution
UC151XD In distribution
60021987-R In distribution
UC310 In distribution
UCB2 In distribution
60022043 In distribution
UC152XD In distribution
UC340 In distribution
ST16 In distribution
60040470S In distribution
UC153 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Prolystica Steris Corporation 41
Ultra Clean Systems Getinge Disinfection AB 33
Henry Schein Henry Schein, Inc. 33
Steelco Steelco SPA 16
BrandMax Tri-Clean Brandmax 12
Alconox Alconox, LLC 11
Valsure Steris Corporation 11
Darby Dental Supply, LLC Darby Dental Supply, LLC 10
Detojet Alconox, LLC 9
Liquinox Alconox, LLC 8
Citranox Alconox, LLC 8
Tergazyme Alconox, LLC 8

Showing 12 of 834. All products under Cleaner, Ultrasonic, Medical Instrument

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