Data / Medical devices / Taiwan / Taiwan Aulisa Medical Devices Technologies, Inc.
Taiwan Aulisa Medical Devices Technologies, Inc.: FDA-registered device maker in Taipei City, Taiwan, 9 510(k) clearances
Taiwan Aulisa Medical Devices Technologies, Inc. is registered with the FDA (registration 3014856521) in Taipei City, Taiwan. It lists 6 device types. The FDA files 9 510(k) clearances under its listings, the newest dated February 25, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014856521
- Address
- 6F-2, No. 3-1, YuanQu St., Nangang Dist., Taipei City, Taiwan, 115
- Owner or operator
- Taiwan Aulisa Medical Devices Technologies, Inc. (10058498)
- Roles
- Manufacturer
- First device listed
- October 4, 2018
- Registered through
- 2026
- Brand names listed
- Continuous Measurement Thermometer, Oximeter, Oximeter TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCYMonitor, temperature, dialysis, OximeterTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY, System, network and communication, physiological monitorsMonitor, physiological, patient (without arrhythmia detection o
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Temperature, Dialysis | FLA | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
| System, Network And Communication, Physiological Monitors | MSX | 2 | Manufacturer | accessdata.fda.gov |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 25, 2025 | K233963 | Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) | DQA | Substantially Equivalent | Taiwan Aulisa Medical Devices Technologies, Inc. | accessdata.fda.gov |
| January 30, 2025 | K233956 | Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) | DQA | Substantially Equivalent | Taiwan Aulisa Medical Devices Technologies, Inc. | accessdata.fda.gov |
| September 27, 2024 | K240220 | Aulisa Temperature Module (TM0002) | FLL | Substantially Equivalent | Taiwan Aulisa Medical Devices Technologies, Inc. | accessdata.fda.gov |
| June 12, 2022 | K203208 | Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System | DQA | Substantially Equivalent | Taiwan Aulisa Medical Devices Technologies, Inc. | accessdata.fda.gov |
| October 30, 2020 | K202497 | Aulisa Multiple Patient Digital Vital Sign Monitoring System | MSX | Substantially Equivalent | Taiwan Aulisa Medical Devices Technologies, Inc. | accessdata.fda.gov |
| June 25, 2019 | K191207 | Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System | DQA | Substantially Equivalent | Taiwan Aulisa Medical Devices Technologies, Inc. | accessdata.fda.gov |
| March 1, 2019 | K183067 | Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System | DQA | Substantially Equivalent | Taiwan Aulisa Medical Devices Technologies, Inc. | accessdata.fda.gov |
| March 1, 2019 | K182822 | Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System | DQA | Substantially Equivalent | Taiwan Aulisa Medical Devices Technologies, Inc. | accessdata.fda.gov |
| March 3, 2017 | K162580 | Guardian Angel GA1000 Digital Vital Sign Monitoring System | DQA | Substantially Equivalent | Taiwan Aulisa Medical Devices Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter
- All makers of Transmitters And Receivers, Physiological Signal, Radiofrequency
- All makers of Continuous Measurement Thermometer
- All makers of System, Network And Communication, Physiological Monitors
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of Monitor, Temperature, Dialysis
Updated February 25, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.