FDA Registration
Active
🇨🇳 China
Amphenol Medical Technologies (Dongguan) Co., Ltd.
Reg #: 3013596024
·
FEI: 3013596024
·
Expires 2025
Products
20
Proprietary Names
0
Establishment Types
1
Classifications
20
Registration Details
- Registration Name
- Amphenol Medical Technologies (Dongguan) Co., Ltd.
- Registration Number
- 3013596024
- FEI Number
- 3013596024
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.2, Xinhu Industrial Park, Qiaolong Road, Dengwu Village, Qiaotou
- City
- Dongguan Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K133882
Owner / Operator
- Firm Name
- Amphenol Critical Medical Technologies, LLC
- Operator Number
- 10053883
- Address
- 9586 Distribution Avenue, Suite F
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
US Agent
- Business Name
- Amphenol Critical Medical Technologies, LLC
- Contact Name
- Lamont Rohde
- Address
- 9586 Distribution Avenue, Suite F
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
- [email protected]
- Phone
- 602 7503539
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Gas, Nitrogen, Gaseous-Phase | CCI | Class 2 | Anesthesiology | No | 2017-12-19 |
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2017-12-19 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2017-12-19 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2017-12-19 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2017-12-19 |
| Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep. | DOA | Class 2 | Clinical Toxicology | No | 2017-12-19 |
| Display, Cathode-Ray Tube, Medical | DXJ | Class 2 | Cardiovascular | No | 2017-12-19 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2017-12-19 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2017-12-19 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2017-12-19 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2017-12-19 |
| Analyzer, Gas, Helium, Gaseous-Phase | BSE | Class 2 | Anesthesiology | No | 2017-12-19 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2017-12-19 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2017-12-19 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2017-12-19 |
| Probe, Blood-Flow, Extravascular | DPT | Class 2 | Cardiovascular | No | 2017-12-19 |
| Analyzer, Gas, Argon, Gaseous-Phase | JEG | Class 2 | Anesthesiology | No | 2017-12-19 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2017-12-19 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2017-12-19 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2017-12-19 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)