FDA Registration
Active
🇨🇳 China
DONGGUAN BAO KANG DIAN ZI KE JI LIMITED
Reg #: 3020978007
·
FEI: 3020978007
·
Expires 2026
Products
24
Proprietary Names
17
Establishment Types
1
Classifications
24
Registration Details
- Registration Name
- DONGGUAN BAO KANG DIAN ZI KE JI LIMITED
- Registration Number
- 3020978007
- FEI Number
- 3020978007
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 8-1, Wen Yu Road, Zhangmutou Town
- City
- Dongguan City Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- HEALTHCARE TECHNOLOGY INTERNATIONAL LTD.
- Operator Number
- 9058334
- Address
- Units 15-21, 12/F, Topsail Plaza,, 11 On Sum Street,
- City
- Shek Mun, Shatin
- State
- HK-NOTA
- Postal Code
- --
- Country
- HK
US Agent
- Business Name
- Law Offices Of Albert Wai-Kit Chan
- Contact Name
- Albert Wai-Kit Chan
- Address
- Law Offices Of Albert Wai-Kit Chan, PLLC World Plaza, Suite 604 141-07 20th Avenue
- City
- Whitestone
- State
- NY
- ZIP
- 11357
- Country
- US
- [email protected]
- Phone
- 718 7991000
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2014-08-27 |
| Dermal Cooling Pack/Vacuum/Massager | OOK | Class 2 | General, Plastic Surgery | No | 2013-01-14 |
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2011-11-15 |
| Pouch, Colostomy | EZQ | Class 1 | Gastroenterology, Urology | No | 2021-10-31 |
| Device, Pressure Applying | KNM | Class 1 | Physical Medicine | No | 2022-06-17 |
| Intra-Abdominal Pressure Monitoring Device | PHU | Class U | Unknown | No | 2020-01-06 |
| Uroflowmeter | EXY | Class 2 | Gastroenterology, Urology | No | 2020-01-06 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2020-01-06 |
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | LBS | Class 1 | Clinical Chemistry | No | 2021-11-01 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2021-11-01 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2021-11-01 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2021-11-01 |
| Colorimetric Method, Triglycerides | JGY | Class 1 | Clinical Chemistry | No | 2021-11-01 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2023-08-03 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2023-02-28 |
| Oximeter, Wellness | PGJ | Class 2 | Cardiovascular | No | 2023-08-14 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2019-01-04 |
| Micro Pipette | JRC | Class 1 | Clinical Chemistry | No | 2017-08-07 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2026-05-12 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2023-08-10 |
| Massager, Powered Inflatable Tube | IRP | Class 2 | Physical Medicine | No | 2018-10-07 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2018-10-07 |
| Warmer, Thermal, Infusion Fluid | LGZ | Class 2 | General Hospital | No | 2012-07-03 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2014-12-03 |
Proprietary Names
i-STAT Alinity Base Station
i-STAT Printer Kit
i-STAT Alinity Printer Kit
i-STAT Alinity Battery
i-STAT Portable Printer
i-STAT 9V NiMH rechargeable battery
Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System
Theragun PRO PLUS
Accuryn SmartFoley IAP UO Temp Tray System
Accuryn SmartFoley UO Temp Tray System
AccuTab
Accuryn Monitoring System
G3PRO
Theragun Pro
Theragun Elite
Theragun Prime Plus
I-STAT Dispensing Tip
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)