Dongguan BAO Kang Dian ZI KE JI Limited
Registered establishment in Dongguan, Guangdong, China. 24 device types.
Dongguan BAO Kang Dian ZI KE JI Limited is a contract manufacturer holding a current FDA establishment registration. The registration covers Arthroscope, Uroflowmeter and 22 other device types. Its earliest product listing with the FDA dates from 2009.
Registration
| Registered name | DONGGUAN BAO KANG DIAN ZI KE JI LIMITED |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3020978007 |
| FEI number | 3020978007 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Dongguan |
|---|---|
| Province | Guangdong |
| Address | No. 8-1, Wen Yu Road, Zhangmutou Town |
| Postal code | / |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Class 1 | 2021 | 16 | |
| Arthroscope | Class 2 | 2014 | 21 | |
| Calculator/Data Processing Module, For Clinical Use | Class 1 | i-STAT Alinity Printer Kit, i-STAT Alinity Base Station, i-STAT Printer Kit, i-STAT Portable Printer, i-STAT Alinity Battery, i-STAT 9V NiMH rechargeable battery | 2011 | 7 |
| Catheter, Retention Type, Balloon | Class 2 | Accuryn SmartFoley UO Temp Tray System, Accuryn SmartFoley IAP UO Temp Tray System, AccuTab, Accuryn Monitoring System, Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System | 2020 | 17 |
| Colorimetric Method, Triglycerides | Class 1 | 2021 | 5 | |
| Dermal Cooling Pack/Vacuum/Massager | Class 2 | 2013 | 3 | |
| Device, Pressure Applying | Class 1 | 2022 | 36 | |
| Enzymatic Esterase–Oxidase, Cholesterol | Class 1 | 2009 | 9 | |
| Glucose Oxidase, Glucose | Class 2 | 2021 | 8 | |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class 1 | 2026 | 23 | |
| Intra-Abdominal Pressure Monitoring Device | Class U | Accuryn SmartFoley UO Temp Tray System, Accuryn SmartFoley IAP UO Temp Tray System, AccuTab, Accuryn Monitoring System, Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System | 2020 | 4 |
| Lamp, Infrared, Therapeutic Heating | Class 2 | Theragun PRO PLUS | 2023 | 235 |
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | Class 1 | 2021 | 2 | |
| Massager, Powered Inflatable Tube | Class 2 | 2018 | 37 | |
| Massager, Therapeutic, Electric | Class 1 | G3PRO, Theragun Elite, Theragun Pro, Theragun PRO PLUS, Theragun Prime Plus | 2019 | 437 |
| Medical Device Data System | Class 1 | Accuryn SmartFoley UO Temp Tray System, Accuryn SmartFoley IAP UO Temp Tray System, AccuTab, Accuryn Monitoring System | 2023 | 11 |
| Micro Pipette | Class 1 | I-STAT Dispensing Tip | 2017 | 29 |
| Oximeter, Wellness | Class 2 | Theragun PRO PLUS | 2023 | 19 |
| Pack, Hot Or Cold, Reusable | Class 1 | Theragun PRO PLUS | 2018 | 178 |
| Pad, Heating, Powered | Class 2 | Theragun PRO PLUS | 2023 | 144 |
| Pouch, Colostomy | Class 1 | 2021 | 25 | |
| Test, Luteinizing Hormone (Lh), Over The Counter | Class 1 | 2014 | 38 | |
| Uroflowmeter | Class 2 | Accuryn SmartFoley UO Temp Tray System, Accuryn SmartFoley IAP UO Temp Tray System, AccuTab, Accuryn Monitoring System, Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System | 2020 | 7 |
| Warmer, Thermal, Infusion Fluid | Class 2 | 2012 | 1 |
Nearby Manufacturers
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.
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