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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.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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 (33–42 cm arm circumference), 6NRMI-K Cuff (22–33 cm arm circumference), 6NRSI-K Cuff (15–22 cm arm circumference), 6NRUI-K Cuff (22–42 cm arm circumference), 6NRXI-K Cuff (2–52 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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 27, 2026K252448AViTA Pulse Oximeter (SP61)DQASubstantially EquivalentAvita Corporationaccessdata.fda.gov
September 3, 2025K250765AViTA Arm Type Blood Pressure Monitor CuffDXQSubstantially EquivalentAvita Corporationaccessdata.fda.gov
February 19, 2025K242455AViTA Pulse Oximeter (SP62B)DQASubstantially EquivalentAvita Corporationaccessdata.fda.gov
October 22, 2024K242193Arm Type Blood Pressure Monitor (BPM82)DXNSubstantially EquivalentAvita Corporationaccessdata.fda.gov
May 20, 2024K223399AViTA Pulse OximeterDQASubstantially EquivalentAvita Corporationaccessdata.fda.gov
December 17, 2020K200346Wrist Type Blood Pressure MonitorDXNSubstantially EquivalentAvita Corporationaccessdata.fda.gov
August 3, 2018K180155Arm Type Blood Pressure MonitorDXNSubstantially EquivalentAvita Corporationaccessdata.fda.gov
July 23, 2018K181242Braun BNT400 No Touch + Forehead ThermometerFLLSubstantially EquivalentKaz USA, Inc., A Helen of Troy Companyaccessdata.fda.gov
July 18, 2018K181015Braun BFH175 Infrared Forehead ThermometerFLLSubstantially EquivalentKaz USA, Inc., A Helen of Troy Companyaccessdata.fda.gov
April 19, 2018K172427AViTA Radar Thermo NT16 Series IR ThermometerFLLSubstantially EquivalentAvita Corporationaccessdata.fda.gov
April 21, 2017K163516Braun No Touch + Forehead NTF3000 ThermometerFLLSubstantially EquivalentKaz USA, Inc., A Helen of Troy Companyaccessdata.fda.gov
May 21, 2014K134043NO TOUCH+FOREHEAD NTF 3000 THERMOMETERFLLSubstantially EquivalentKaz USA, Inc (A Subsidiaryof Kaz Inc)accessdata.fda.gov
June 1, 2012K120672KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITORDXNSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
January 18, 2012K112825AVITA ARM TYPE BLOOD PRESSURE MONITORDXNSubstantially EquivalentAvita Corporationaccessdata.fda.gov
January 6, 2012K110559AVITA INFRARED THEROMETER WITH BLUETOOTHFLLSubstantially EquivalentAvita Corporationaccessdata.fda.gov
March 3, 2011K102554AVITA SCANEO IR THERMOMETER MODEL TS4X SERIESFLLSubstantially EquivalentAvita Corporationaccessdata.fda.gov
December 16, 2010K102624AVITA WRIST TYPE BLOOD PRESSURE MONITORDXNSubstantially EquivalentAvita Corporationaccessdata.fda.gov
May 26, 2010K090379AVITA NASAL ASPIRATOR, MODEL, NS1 SERIESBTASubstantially EquivalentAvita Corporationaccessdata.fda.gov
March 4, 2010K100016AVITA SCANEO INFRARED EAR THERMOMETER, MODEL TS7FLLSubstantially EquivalentAvita Corporationaccessdata.fda.gov
December 2, 2009K092958AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIESFLLSubstantially EquivalentAvita Corporationaccessdata.fda.gov
June 24, 2008K081160AVITA RADAR THERMO IR THERMOMETER, NT1 SERIESFLLSubstantially EquivalentAvita Corporationaccessdata.fda.gov
December 7, 2007K072137AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZBDXNSubstantially EquivalentAvita Corporationaccessdata.fda.gov
April 9, 2004K033397AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BPM6XYDXNSubstantially EquivalentAvita Corporationaccessdata.fda.gov
April 11, 2001K010462AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)FLLSubstantially EquivalentAvita Corporationaccessdata.fda.gov

Compare with other makers

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.