FDA Registration
Active
🇨🇳 China
Chest suction electrodes, Limb clamps electrodes, Disposable ECG monitoring electrodes, Prewired neonate ECG electrodes
Reg #: 3013783488
·
FEI: 3013783488
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ORANTECH INC.
- Registration Number
- 3013783488
- FEI Number
- 3013783488
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Zone#A,4F,1st Bld,7th Industrial Zone,Yulv Community, GongMing, Guangming New District,
- City
- Shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Orantech Inc.
- Operator Number
- 10058634
- Address
- Zone#A,4F,1st Bld,7th Industrial Zone,Yulv Community, GongMing, Guangming New District,
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518106
- Country
- CN
- Correspondent
- Yuanlan Zeng
US Agent
- Business Name
- Medten USA Inc.
- Contact Name
- Andres Orjuela
- Address
- 1 Technology Dr. Suite B115 Irvine, CA 92618
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
- [email protected]
- Phone
- 925 3599115
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2022-03-31 |
Proprietary Names
Chest suction electrodes, Limb clamps electrodes, Disposable ECG monitoring electrodes, Prewired neonate ECG electrodes
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device