FDA Registration
Active
🇨🇳 China
Aneroid Sphygmomanometer
Reg #: 9680638
·
FEI: 3005667208
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- CARDICARE COMPANY, LTD.
- Registration Number
- 9680638
- FEI Number
- 3005667208
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 27 Huashan Road Gaochun Economy Zone
- City
- NANJING Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K222652
Owner / Operator
- Firm Name
- CARDICARE COMPANY, LTD.
- Operator Number
- 9010325
- Address
- 9 YAN AN ROAD, WU SHAN PLAZA TOWN, UNIT 7003
- City
- HANGZHOU
- State
- Zhejiang
- Postal Code
- 310002
- 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 |
|---|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2022-11-29 |
Proprietary Names
Aneroid Sphygmomanometer
01-155-011,01-160-021,01-160-071,01-160-081,01-160-151,01-160-161,01-160-201,01-160-211,01-160-241,01-160-251
06-214-191,06-270-191,06-270-131,06-270-195,06-270-196,09-141-011,09-141-015,09-141-016,09-149-011,09-149-015,09-149-016
01-260-021,01-260-071,01-260-081,01-260-151,01-260-161,01-260-201,01-260-211,01-260-241,01-260-251,01-350-018
Single Patient Use Aneroid Sphygmomanometer
01-365-021,01-365-211,04-174-021,04-174-026,04-176-021,04-176-026,06-148-131,06-148-191,06-148-195,06-148-196
01-350-058,01-360-021,01-360-051,01-360-071,01-360-151,01-360-161,01-360-201,01-360-211,01-360-241,01-360-251
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device