FDA Registration
Active
🇰🇭 Cambodia
Health Sense Upper Arm Blood Pressure Monitor
Reg #: 3024790242
·
FEI: 3024790242
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- RENS MEDCARE (CAMBODIA) CO.,LTD.
- Registration Number
- 3024790242
- FEI Number
- 3024790242
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- B-06-02, Sihanoukville SEZ
- City
- Sihanouk Preah Sihanouk
- Country
- KH
Regulatory Submissions
- 510(k) Number
- K173024
Owner / Operator
- Firm Name
- JOYTECH HEALTHCARE CO. LTD.
- Operator Number
- 10054061
- Address
- No.365, Wuzhou Road
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 311100
- Country
- CN
- Correspondent
- Yunhua Ren
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2018-08-23 |
Proprietary Names
Health Sense Upper Arm Blood Pressure Monitor
healthsmart Premium Series Upper Arm Blood Pressure Monitor Item: 04-655-001
Talking Sense Blood Pressure Monitor
Maverick Blood Pressure Monitor
MABIS Universal Arm Talking Blood Pressure Monitor Item: 04-650-001
healthsmart Select Series Upper Arm Blood Pressure Monitor Item: 04-645-001
healthsmart Standard Series Upper Arm Blood Pressure Monitor Item: 04-635-001
Establishment Types
Manufacture Medical Device