FDA Registration
Active
🇨🇳 China
HHYLOGY, Blood pressure monitor, model: MD-H21
Reg #: 3013561145
·
FEI: 3013561145
·
Expires 2025
Products
1
Proprietary Names
8
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
- K171833
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 | 2018-02-08 |
Proprietary Names
HHYLOGY, Blood pressure monitor, model: MD-H21
HOMIEE, Blood pressure monitor, model: BP2001
Wrist Style, Blood pressure monitor, model: BP800W BP603W BP880W BP885W BPCBOA-2F BP850W BP300W
Dynarex, Blood pressure monitor, model: 7095
Wrist Style, Blood pressure monitor, model: BP810W BP602W BP608W BP606W BP660W BP830W BP866W
CHOICEMMED, Blood pressure monitor, model: CBP2K1
CHOICEMMED, Blood pressure monitor, model: CBP2K3
CHOICEMMED, Blood pressure monitor, model: CBP2K2
Establishment Types
Manufacture Medical Device