FDA Registration
Active
🇨🇳 China
DIGITAL ELECTRONIC THERMOM
Reg #: 3004215929
·
FEI: 3004215929
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- COTRONIC TECHNOLOGY LIMITED
- Registration Number
- 3004215929
- FEI Number
- 3004215929
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Floor 4-6, Block 7, West of ZhouShi Road, XiXiang Street, BaoAn Zone
- City
- SHENZHEN, GUANG DONG PROVINCE Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K032434
Owner / Operator
- Firm Name
- COTRONIC TECHNOLOGY LIMITED
- Operator Number
- 9057884
- Address
- FLOOR 4, BLOCK 4, FU YUAN IND, ZONE,JIU WEI,XING XIANG, BAO AN
- City
- SHEN ZHEN
- State
- Guangdong
- Postal Code
- 518126
- Country
- CN
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr.
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2003-11-14 |
Proprietary Names
DIGITAL ELECTRONIC THERMOM
TM01, TM02/ TM08, TM09S, TM12FE, TM12F, MT804, TM13
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device