DxU
DxU 1800 System Bridge System bridge is an interface for the DxU 1800c fully automated urine chemistry analyzer that facilitates post-analytical processing and the transfer of patient…
DxU 1800 System Bridge System bridge is an interface for the DxU 1800c fully automated urine chemistry analyzer that facilitates post-analytical processing and the transfer of patient samples within a clinical laboratory.
Who Else Makes It
Concentrated in Jiangsu (17), Zhejiang (15), Guangdong (13). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Jiangsu Kangjian Medical Apparatus Co., Ltd. | Jiangyan | Jiangsu | Contract manufacturer | 19 |
| Yancheng Huida Medical Instruments Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 10 |
| Yantai Addcare Bio-Tech Co., Ltd. | Yantai | Shandong | Contract manufacturer | 8 |
| HUA Cheng XIN Plastic Mold Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Guangzhou Komaspec Mechanical AND Electrical Products Manufa | Huashan Town, Huadu District | Guangdong | Contract manufacturer | 4 |
| Inplast Plastic & Electronics Co., Ltd. | Suzhou New District | Jiangsu | Contract manufacturer | 2 |
| Flextronics Medical Molding (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
Showing 12 of 72. All 72 manufacturers in China registered for Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Record
| Listed by | Beckman Coulter, Inc., United States |
|---|---|
| FDA product code | LXG |
| Device type | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2050 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2026-06-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D39794 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Globe Scientific | Globe Scientific, LLC | 144 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Scientific Device Laboratory, Inc. | 61 |
| Gongdong | Zhejiang Gongdong Medical Technology Co., Ltd. | 26 |
| Cardinal Health | Cardinal Health 200, LLC | 24 |
| De-/Recapper 900 Flex ID, 115V | Sarstedt Aktiengesellschaft & Co.KG | 20 |
| CellSHILED | Equashield Medical Ltd | 19 |
| Porex SQ-Easy | Porex Corporation | 17 |
| Corning | Corning Incorporated | 15 |
| Pathfinder | AIM LAB Automation Technologies PTY Ltd | 15 |
| Yingtai | Changsha Yingtai Instrument Co., Ltd. | 13 |
| Helmer Scientific | Helmer Inc. | 12 |
| Kbmed | KB Medical (Group) Inc. | 11 |
Showing 12 of 424. All products under Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-05-07 | Not classified | Other | The recall was initiated because Beckman Coulter has confirmed an issue with the AutoMate Sample Processing Systems. If during the recovery from Error 81201001, a stuck sample carrier with a tube is moved backwards to the loading position | 5 units total | 2012-06-28 |
| 2007-02-22 | Not classified | Labeling design | Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented. | 9 in the U.S.; 1 in Canada | 2012-04-26 |
| 2006-06-26 | Not classified | Other | During the cleaning cycle performed during the shutdown procedure of the Beckman Coulter FP1000 Cell Preparation System, fluid (diluted bleach) may drip from the probe in the location of the back reagent rack potentially resulting in bleach | 11 units distributed | 2012-04-26 |
| 2006-05-22 | Not classified | Other | Beckman Coulter has determined that under certain conditions a system error generated during a Pause and Rotate routine may result in a sample misidentification with a risk of reporting erroneous results. | 424 | 2012-04-26 |
| 2005-05-05 | Not classified | Process change control | Device does not maintain a uniform internal temperature within 2-8 C at warmer ambient temperatures. | 46 | 2012-03-07 |
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.