Data / Medical devices / Taiwan / Avita Corporation
Avita Corporation: FDA-registered device maker in San-Chung District, New Taipei City, Taiwan, 14 510(k) clearances
Avita Corporation is registered with the FDA (registration 9617543) in San-Chung District, New Taipei City, Taiwan. It lists 10 device types. The FDA files 14 510(k) clearances under its listings, the newest dated February 19, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9617543
- FEI number
- 3003272793
- Address
- 9F, NO. 78, SEC. 1, Kwang-Fu Road, San-Chung District, New Taipei City, Taiwan, 24158
- Owner or operator
- AViTA CORPORATION (9042237)
- Roles
- Manufacturer, Specification developer
- First device listed
- September 2, 2005
- Registered through
- 2027
- Brand names listed
- AViTA Breast Pump BR10, AViTA NE 10, AViTA NE 20, AViTA NE 60, AViTA Nasal Aspirator NS22, Arm Type Blood Pressure Monitor model: AD-4483, Arm Type Blood Pressure Monitor model:BPM636, Arm Type Blood Pressure Monitor model:BPM65 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bottle, Collection, Vacuum | KDQ | 2 | Manufacturer | accessdata.fda.gov |
| Breast Pump Kit | OHH | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Humidifier Nebulizer Kit | OGG | 2 | Manufacturer | accessdata.fda.gov |
| Irrigator, Powered Nasal | KMA | 1 | Manufacturer | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Oximeter, Infrared, Sporting, Aviation | OCH | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer, Specification developer | 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 19, 2025 | K242455 | AViTA Pulse Oximeter (SP62B) | DQA | Substantially Equivalent | Avita Corporation | accessdata.fda.gov |
| December 31, 2024 | K241852 | Nasal Aspirator (NS 13) | BTA | Substantially Equivalent | Avita Corporation | accessdata.fda.gov |
| October 22, 2024 | K242193 | Arm Type Blood Pressure Monitor (BPM82) | DXN | Substantially Equivalent | Avita Corporation | accessdata.fda.gov |
| May 20, 2024 | K223399 | AViTA Pulse Oximeter | DQA | Substantially Equivalent | Avita Corporation | accessdata.fda.gov |
| August 3, 2018 | K180155 | Arm Type Blood Pressure Monitor | DXN | Substantially Equivalent | Avita Corporation | accessdata.fda.gov |
| July 23, 2018 | K181242 | Braun BNT400 No Touch + Forehead Thermometer | FLL | Substantially Equivalent | Kaz USA, Inc., A Helen of Troy Company | accessdata.fda.gov |
| July 18, 2018 | K181015 | Braun BFH175 Infrared Forehead Thermometer | FLL | Substantially Equivalent | Kaz USA, Inc., A Helen of Troy Company | accessdata.fda.gov |
| April 19, 2018 | K172427 | AViTA Radar Thermo NT16 Series IR Thermometer | FLL | Substantially Equivalent | Avita Corporation | accessdata.fda.gov |
| April 21, 2017 | K163516 | Braun No Touch + Forehead NTF3000 Thermometer | FLL | Substantially Equivalent | Kaz USA, Inc., A Helen of Troy Company | accessdata.fda.gov |
| June 1, 2012 | K120672 | KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Andon Health Co, Ltd. | accessdata.fda.gov |
| January 6, 2012 | K110559 | AVITA INFRARED THEROMETER WITH BLUETOOTH | FLL | Substantially Equivalent | Avita Corporation | accessdata.fda.gov |
| March 3, 2011 | K102554 | AVITA SCANEO IR THERMOMETER MODEL TS4X SERIES | FLL | Substantially Equivalent | Avita Corporation | accessdata.fda.gov |
| May 26, 2010 | K090379 | AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES | BTA | Substantially Equivalent | Avita Corporation | accessdata.fda.gov |
| June 24, 2008 | K081160 | AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES | FLL | Substantially Equivalent | Avita Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Irrigator, Powered Nasal
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Breast Pump Kit
- All makers of Continuous Measurement Thermometer
- All makers of Oximeter
- All makers of Bottle, Collection, Vacuum
Updated February 19, 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.