FDA Registration
Active
🇨🇳 China
Combei, ARM Blood Pressure Monitor, model: BP100A, BP200A, BPCB0A-3A, BP800A, BPCB0A-2A, BP866A, BP105A, BP106A
Reg #: 3013561145
·
FEI: 3013561145
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHENZHEN COMBEI TECHNOLOGY CO.,LTD
- Registration Number
- 3013561145
- FEI Number
- 3013561145
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.105, Huanguan South Road, Dahe, Community, Guanlan, Longhua New District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K163606
Owner / Operator
- Firm Name
- SHENZHEN COMBEI TECHNOLOGY CO.,LTD
- Operator Number
- 10054917
- Address
- No.105, Huanguan South Road, Dahe, Community, Guanlan, Longhua New District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518110
- Country
- CN
- Correspondent
- Kevin Fong
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 | 2017-05-12 |
Proprietary Names
Combei, ARM Blood Pressure Monitor, model: BP100A, BP200A, BPCB0A-3A, BP800A, BPCB0A-2A, BP866A, BP105A, BP106A
Combei, WristBlood Pressure Monitor, model: BP885W, BP606W, BP800W, BP603W, BP880W, BPCB0A-2F, BP850W, BP300W
Combei, ARM Blood Pressure Monitor, model: BP108A, BP116A, BP118A, BP880A, BP168A, BP126A, BP156A
HOMIEE, Blood pressure monitor, model: BP1001, BP1002
Combei, WristBlood Pressure Monitor, model: BP810W, BP602W, BP608W, BP606W, BP830W, BP866W
Establishment Types
Manufacture Medical Device