FDA Registration
Active
🇨🇳 China
Vital Signs Monitor, Model: iM3s, iM3As, iM3Bs, iHM3s
Reg #: 3003971136
·
FEI: 3003971136
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- EDAN INSTRUMENTS, INC.
- Registration Number
- 3003971136
- FEI Number
- 3003971136
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K233038
Owner / Operator
- Firm Name
- EDAN INSTRUMENTS, INC.
- Operator Number
- 9055347
- Address
- #15 Jinhui Road,Jinsha Community, Kengzi Sub-District, Pingshan District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518122
- Country
- CN
US Agent
- Business Name
- Edan Diagnostics, Inc
- Contact Name
- Chao Lin
- Address
- 9918 Via Pasar, San Diego CA
- City
- San Diego
- State
- CA
- ZIP
- 92126
- Country
- US
- [email protected]
- Phone
- 858 7503066
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2024-03-09 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2024-03-09 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2024-03-09 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2024-03-09 |
Proprietary Names
Vital Signs Monitor, Model: iM3s, iM3As, iM3Bs, iHM3s
Establishment Types
Manufacture Medical Device