FDA Registration
Active
🇰🇭 Cambodia
healthsmart Touchless Infrared Thermometer Item: 18-555-0000
Reg #: 3024790242
·
FEI: 3024790242
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
2
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
- K181239
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 |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2018-10-29 |
Proprietary Names
healthsmart Touchless Infrared Thermometer Item: 18-555-0000
Infrared Forehead Thermometer DET-3010,DET-3010b,DET-3011,DET-3011b,DET-3012,DET-3012b,DET-3020,DET-3020b,DET-3015,
Infrared Ear/Forehead Thermometer DET-2126,DET-2126b
healthsmart Talking Infrared Ear & Forehead Thermometer Item: 18-930-000
Infrared Forehead Thermometer DET-3024,DET-3024b,
Infrared Forehead ThermometerDET-3019c,DET-3019b,DET-3021,DET-1000,DET-3000,DET-3022,DET-3023,DET-3023b,
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device