Xi Adapter R2
Catalogue number Xi Adapter R2, listed by Ultra Clean Systems, Inc., under Cleaner, Ultrasonic, Medical Instrument. 48 manufacturers in China are registered for this product code.
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.
| 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
| Listed by | Ultra Clean Systems, Inc. |
|---|---|
| FDA product code | FLG |
| Device type | Cleaner, Ultrasonic, Medical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6150 |
| Premarket notification | Exempt |
| Record published | 2025-07-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
| Packaging | Box of 10, box of 6 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Xi Adapter R2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BioSonic | Coltene/Whaledent Gmbh & Co. KG | 49 |
| 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 |
Showing 12 of 834. All products under Cleaner, Ultrasonic, Medical Instrument
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-03-31 | Class II | Under Investigation by firm | During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation. | 96 systems |
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.