FDA Registration
Active
🇨🇳 China
All-in-One Health Monitor
Reg #: 3006733253
·
FEI: 3006733253
·
Expires 2025
Products
6
Proprietary Names
2
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- SHENZHEN CREATIVE INDUSTRY CO., LTD
- Registration Number
- 3006733253
- FEI Number
- 3006733253
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District
- City
- SHENZHEN Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K170047
Owner / Operator
- Firm Name
- SHENZHEN CREATIVE INDUSTRY CO., LTD
- Operator Number
- 9104865
- Address
- 1001, Building West, Lepu Tower, No.66 Xingke Road, Xili Community, Xili Street, Nanshan District
- City
- SHENZHEN
- State
- Guangdong
- Postal Code
- 518055
- 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 |
|---|---|---|---|---|---|
| Recorder, Magnetic Tape, Medical | DSH | Class 2 | Cardiovascular | No | 2017-09-10 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2017-09-10 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2017-09-10 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2017-09-10 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2017-09-10 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2017-09-10 |
Proprietary Names
All-in-One Health Monitor
PC-303
Establishment Types
Manufacture Medical Device