Data / Medical devices / China / Avita (wujiang) Co., Ltd
Avita (wujiang) Co., Ltd: FDA-registered device maker in Wujiang City Jiangsu, China, 24 510(k) clearances
Avita (wujiang) Co., Ltd is registered with the FDA (registration 3004727197) in Wujiang City Jiangsu, China. It lists 15 device types. The FDA files 24 510(k) clearances under its listings, the newest dated February 27, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004727197
- Address
- No.858.Jiao Tong Road Wujiang Economic Development Zone, Wujiang City Jiangsu, China, 215200
- Owner or operator
- AViTA (WUJIANG) CO., LTD (9066962)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- September 2, 2005
- Registered through
- 2026
- Brand names listed
- 6NRLI-K Cuff (3342 cm arm circumference), 6NRMI-K Cuff (2233 cm arm circumference), 6NRSI-K Cuff (1522 cm arm circumference), 6NRUI-K Cuff (2242 cm arm circumference), 6NRXI-K Cuff (252 cm arm circumference), AViTA Breast Pump BR10, AViTA Nasal Aspirator NS13, AViTA Nasal Aspirator NS24 and more
Devices it lists
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 27, 2026 | K252448 | AViTA Pulse Oximeter (SP61) | DQA | Substantially Equivalent | Avita Corporation | accessdata.fda.gov |
| September 3, 2025 | K250765 | AViTA Arm Type Blood Pressure Monitor Cuff | DXQ | Substantially Equivalent | Avita Corporation | accessdata.fda.gov |
| February 19, 2025 | K242455 | AViTA Pulse Oximeter (SP62B) | DQA | 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 |
| December 17, 2020 | K200346 | Wrist Type Blood Pressure Monitor | DXN | 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 |
| May 21, 2014 | K134043 | NO TOUCH+FOREHEAD NTF 3000 THERMOMETER | FLL | Substantially Equivalent | Kaz USA, Inc (A Subsidiaryof Kaz Inc) | 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 18, 2012 | K112825 | AVITA ARM TYPE BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Avita Corporation | 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 |
| December 16, 2010 | K102624 | AVITA WRIST TYPE BLOOD PRESSURE MONITOR | DXN | 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 |
| March 4, 2010 | K100016 | AVITA SCANEO INFRARED EAR THERMOMETER, MODEL TS7 | FLL | Substantially Equivalent | Avita Corporation | accessdata.fda.gov |
| December 2, 2009 | K092958 | AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES | FLL | 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 |
| December 7, 2007 | K072137 | AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZB | DXN | Substantially Equivalent | Avita Corporation | accessdata.fda.gov |
| April 9, 2004 | K033397 | AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BPM6XY | DXN | Substantially Equivalent | Avita Corporation | accessdata.fda.gov |
| April 11, 2001 | K010462 | AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) | FLL | Substantially Equivalent | Avita Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
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- All makers of Detectors And Removers, Lice, (Including Combs)
- All makers of Irrigator, Powered Nasal
- All makers of Instrument, Manual, Surgical, General Use
- All makers of Transmitters And Receivers, Physiological Signal, Radiofrequency
Updated February 27, 2026. 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.