FDA Registration
Active
🇨🇳 China
ORANTECH INC.
Reg #: 3013783488
·
FEI: 3013783488
·
Expires 2025
Products
20
Proprietary Names
0
Establishment Types
1
Classifications
20
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
Regulatory Submissions
- 510(k) Number
- K140535
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 |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2022-04-23 |
| Monitor, Uterine Contraction, External (For Use In Clinic) | HFM | Class 2 | Obstetrics/Gynecology | No | 2022-04-23 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2022-04-23 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2022-04-23 |
| System, Monitoring, Perinatal | HGM | Class 2 | Obstetrics/Gynecology | No | 2022-04-23 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2022-04-23 |
| Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | JOM | Class 2 | Cardiovascular | No | 2022-04-23 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2022-04-23 |
| Transducer, Ultrasonic, Obstetric | HGL | Class 2 | Obstetrics/Gynecology | No | 2022-04-23 |
| Transducer, Pressure, Intrauterine | HFN | Class 2 | Obstetrics/Gynecology | No | 2022-04-23 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2022-04-23 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2022-04-23 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2022-04-23 |
| Recorder, Paper Chart | DSF | Class 1 | Cardiovascular | No | 2022-04-23 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2022-04-23 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2022-04-23 |
| Amplifier And Signal Conditioner, Transducer Signal | DRQ | Class 2 | Cardiovascular | No | 2022-04-23 |
| Transducer, Blood-Pressure, Extravascular | DRS | Class 2 | Cardiovascular | No | 2022-04-23 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2022-04-23 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2022-04-23 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device