FDA Registration
Active
🇨🇳 China
Electronic Blood Pressure Monitor for Upper Arm, BPA001, BPA002
Reg #: 3008395508
·
FEI: 3008395508
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Guangzhou Berrcom Medical Device Co., Ltd
- Registration Number
- 3008395508
- FEI Number
- 3008395508
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.38 Huanzhen Xi Road, Dagang Town, Nansha
- City
- Guangzhou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K130232
Owner / Operator
- Firm Name
- Guangzhou Berrcom Medical Device Co., Ltd
- Operator Number
- 10032524
- Address
- No.38 Huanzhen Xi Road, Dagang Town, Nansha
- City
- Guangzhou
- State
- Guangdong
- Postal Code
- 511470
- Country
- CN
- Correspondent
- Jiacheng Guo
US Agent
- Business Name
- Shenzhen Joyantech Consulting Co., Ltd.
- Contact Name
- Thomas Tang
- Address
- 25 Hopewell Drive Stony Brook
- City
- Stony Brook
- State
- NY
- ZIP
- 11790
- Country
- US
- [email protected]
- Phone
- 631 7511103
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2013-12-17 |
Proprietary Names
Electronic Blood Pressure Monitor for Upper Arm, BPA001, BPA002
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device