FDA Registration
Active
🇨🇳 China
Upper Arm Blood Pressure Monitor(Model No.: FDBP-A1,FDBP-A2,FDBP-A3,FDBP-A4,FDBP-A5,FDBP-A6,FDBP-A7)
Reg #: 3005621440
·
FEI: 3005621440
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FAMIDOC TECHNOLOGY CO., LTD
- Registration Number
- 3005621440
- FEI Number
- 3005621440
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 401,501, 601, 901, Building 6 ,Zhongtang tian'An Cyber Park, No. 89, Jinyuan Road, Zhongtang Town
- City
- Dong Guan Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K191673
Owner / Operator
- Firm Name
- FAMIDOC TECHNOLOGY CO., LTD.
- Operator Number
- 9078379
- Address
- Room 401,501,601,901 Building 6, Zhongtang Tian'an Cyber Park, No. 89, Jinyuan Road, Zhongtang Town
- City
- Dongguan
- State
- Guangdong
- Postal Code
- 523220
- Country
- CN
US Agent
- Business Name
- clinical guard
- Contact Name
- Yue Zhang
- Address
- 2625 Piedmont Rd Ne Ste 56-129 Atlanta Ga 30324
- City
- Atlanta
- State
- GA
- ZIP
- 30324
- Country
- US
- [email protected]
- Phone
- 678 8026200
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2019-12-03 |
Proprietary Names
Upper Arm Blood Pressure Monitor(Model No.: FDBP-A1,FDBP-A2,FDBP-A3,FDBP-A4,FDBP-A5,FDBP-A6,FDBP-A7)
Upper Arm Blood Pressure Monitor(Model No.: FDBP-A15,FDBP-A16,FDBP-A17,FDBP-A18,FDBP-A19,FDBP-A20,FDBP-A21)
Upper Arm Blood Pressure Monitor(Model No.: FDBP-A8,FDBP-A9,FDBP-A10,FDBP-A11,FDBP-A12,FDBP-A13,FDBP-A14)
Upper Arm Blood Pressure Monitor(model number:BPA-800-WT)
Upper arm blood pressure monitor(Model:ExactFit 2,BUA4050US)
Upper arm blood pressure monitor (ModelExactFit 1E, BUA4000US)
Establishment Types
Manufacture Medical Device