FDA Registration
Active
🇨🇳 China
EMI (DONGGUAN) ASIA LIMITED
Reg #: 3017422354
·
FEI: 3017422354
·
Expires 2025
Products
9
Proprietary Names
0
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- EMI (DONGGUAN) ASIA LIMITED
- Registration Number
- 3017422354
- FEI Number
- 3017422354
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Lot No. 5, Chuangying Road Dongcheng Section,, Dongcheng District,
- City
- Dongguan City Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K142430
Owner / Operator
- Firm Name
- Registrar Corp
- Operator Number
- 10088978
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- Postal Code
- 23666
- Country
- US
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dc-Defibrillator, Low-Energy, (Including Paddles) | LDD | Class 2 | Cardiovascular | No | 2023-10-25 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2023-10-25 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2023-10-25 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2023-10-25 |
| Automated External Defibrillators (Non-Wearable) | MKJ | Class 3 | Cardiovascular | No | 2023-10-25 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2023-10-25 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2023-10-25 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2023-10-25 |
| Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | DRO | Class 2 | Cardiovascular | No | 2023-10-25 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)