FDA Registration
Active
🇨🇳 China
Transcranial Doppler Ultrasound System
Reg #: 3006441164
·
FEI: 3006441164
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- SHENZHEN DELICA MEDICAL EQUIPMENT CO., LTD.
- Registration Number
- 3006441164
- FEI Number
- 3006441164
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 18F, Building B, High-tech park, Guangqiao Road, Tianliao Community,, Yutang Street, Guangming District,
- City
- SHENZHEN Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K190228
Owner / Operator
- Firm Name
- SHENZHEN DELICA MEDICAL EQUIPMENT CO., LTD.
- Operator Number
- 9081823
- Address
- 18F, Building B, High-tech park, Guangqiao Road, Tianliao Community, Yutang Street, Guangming District,
- City
- SHENZHEN
- State
- Guangdong
- Postal Code
- 518107
- Country
- CN
US Agent
- Business Name
- QA/RA Consulting Group, Inc.
- Contact Name
- Scott Bednar
- Address
- 3335 Tuscarawas Road
- City
- Beaver
- State
- PA
- ZIP
- 15009
- Country
- US
- [email protected]
- Phone
- 412 4188066
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2019-06-18 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2019-06-18 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2019-06-18 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2019-06-18 |
| Diagnostic Ultrasonic Transducer, Robotic | OQQ | Class 2 | Radiology | No | 2019-06-18 |
Proprietary Names
Transcranial Doppler Ultrasound System
Establishment Types
Manufacture Medical Device