FDA Registration
Active
🇹🇼 Taiwan
TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC.
Reg #: 3014856521
·
FEI: 3014856521
·
Expires 2026
Products
6
Proprietary Names
5
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC.
- Registration Number
- 3014856521
- FEI Number
- 3014856521
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6F-2, No. 3-1, YuanQu St., Nangang Dist.
- City
- Taipei City
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K202497
Owner / Operator
- Firm Name
- Taiwan Aulisa Medical Devices Technologies, Inc.
- Operator Number
- 10058498
- Address
- 6F-2, No. 3-1, YuanQu St., Nangang Dist.
- City
- Taipei City
- State
- TW-TPE
- Postal Code
- 11503
- Country
- TW
- Correspondent
- Augustine Lien
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2020-11-19 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2020-11-19 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2019-07-16 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2019-07-16 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2024-10-30 |
| Monitor, Temperature, Dialysis | FLA | Class 2 | Gastroenterology, Urology | No | 2023-10-25 |
Proprietary Names
System, network and communication, physiological monitorsMonitor, physiological, patient (without arrhythmia detection o
OximeterTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
Oximeter
Continuous Measurement Thermometer
Oximeter TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCYMonitor, temperature, dialysis
Establishment Types
Manufacture Medical Device