FDA Registration
Active
🇹🇼 Taiwan
Airway Elbow Adapter, Disposable
Reg #: 8043316
·
FEI: 3003319165
·
Expires 2025
Products
20
Proprietary Names
3
Establishment Types
1
Classifications
20
Registration Details
- Registration Name
- GALEMED CORP.
- Registration Number
- 8043316
- FEI Number
- 3003319165
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.87, LI-GONG 2ND RD.,
- City
- WU-JIA Yilan
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K133882
Owner / Operator
- Firm Name
- GaleMed Corporation
- Operator Number
- 8043316
- Address
- 87, LI-GONG 2ND RD.,
- City
- Wu-jia
- State
- Yilan
- Postal Code
- 268
- Country
- TW
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2014-11-21 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2014-11-21 |
| Display, Cathode-Ray Tube, Medical | DXJ | Class 2 | Cardiovascular | No | 2014-11-21 |
| Analyzer, Gas, Nitrogen, Gaseous-Phase | CCI | Class 2 | Anesthesiology | No | 2014-11-21 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2014-11-21 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2014-11-21 |
| Analyzer, Gas, Helium, Gaseous-Phase | BSE | Class 2 | Anesthesiology | No | 2014-11-21 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2014-11-21 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2014-11-21 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2014-11-21 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2014-11-21 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2014-11-21 |
| Probe, Blood-Flow, Extravascular | DPT | Class 2 | Cardiovascular | No | 2014-11-21 |
| Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep. | DOA | Class 2 | Clinical Toxicology | No | 2014-11-21 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2014-11-21 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2014-11-21 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2014-11-21 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2014-11-21 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2014-11-21 |
| Analyzer, Gas, Argon, Gaseous-Phase | JEG | Class 2 | Anesthesiology | No | 2014-11-21 |
Proprietary Names
Airway Elbow Adapter, Disposable
Airway Straight T Adapter, Disposable
Adapter for Gas Return
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)