Avita (Wujiang) Co., Ltd.
Registered establishment in Wujiang, Jiangsu, China. 15 device types.
Avita (Wujiang) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Breast Pump Kit and 13 other device types. Its earliest product listing with the FDA dates from 2005.
Registration
| Registered name | AVITA (WUJIANG) CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004727197 |
| FEI number | 3004727197 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Wujiang |
|---|---|
| Province | Jiangsu |
| Address | No.858.Jiao Tong Road |
| Postal code | 215200 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Blood Pressure Cuff | Class 2 | 6NRUI-K Cuff (22 → 42 cm arm circumference), 6NRMI-K Cuff (22 → 33 cm arm circumference), 6NRSI-K Cuff (15 → 22 cm arm circumference), 6NRXI-K Cuff (2 → 52 cm arm circumference), 6NRLI-K Cuff (33 → 42 cm arm circumference) | 2026 | 50 |
| Breast Pump Kit | Class 2 | AViTA Breast Pump BR10 | 2023 | 4 |
| Clinical Electronic Thermometer | Class 2 | Braun Thermoscan 3 EAR Thermometer IRT3030USV2, BRAUN Sensian 4 3-in-1 Thermometer BNT100USV2, Braun Thermoscan 4 EAR Thermometer IRT3515USV2 | 2025 | 49 |
| Continuous Measurement Thermometer | Class 2 | BRAUN Sensian 4 3-in-1 Thermometer BNT100USV2 | 2008 | 115 |
| Detectors And Removers, Lice, (Including Combs) | Class 1 | LC10 | 2014 | 17 |
| Humidifier Nebulizer Kit | Class 2 | 2023 | 1 | |
| Instrument, Manual, Surgical, General Use | Class 1 | 2021 | 110 | |
| Irrigator, Powered Nasal | Class 1 | NS22 | 2005 | 63 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Class 1 | 2025 | 57 | |
| Oximeter | Class 2 | AViTA Pulse Oximeter (SP61) | 2024 | 70 |
| Oximeter, Infrared, Sporting, Aviation | Class 2 | 2023 | 29 | |
| Pad, Heating, Powered | Class 2 | 2024 | 144 | |
| Pump, Portable, Aspiration (Manual Or Powered) | Class 2 | BN005, NS22, AViTA Nasal Aspirator NS13, AViTA Nasal Aspirator NS24, BN007 | 2020 | 14 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | Arm Type Blood Pressure Monitor (BPM82) | 2008 | 98 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | Class 2 | 2008 | 11 |
Clearances
No clearance names Avita (Wujiang) Co., Ltd. as applicant. 24 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252448 | 2026-02-27 | DQA | Traditional | Avita Corporation |
| K250765 | 2025-09-03 | DXQ | Traditional | Avita Corporation |
| K242455 | 2025-02-19 | DQA | Traditional | Avita Corporation |
| K242193 | 2024-10-22 | DXN | Traditional | Avita Corporation |
| K223399 | 2024-05-20 | DQA | Traditional | Avita Corporation |
| K200346 | 2020-12-17 | DXN | Traditional | Avita Corporation |
| K180155 | 2018-08-03 | DXN | Traditional | Avita Corporation |
| K181242 | 2018-07-23 | FLL | Special | Kaz USA, Inc., A Helen of Troy Company |
| K181015 | 2018-07-18 | FLL | Special | Kaz USA, Inc., A Helen of Troy Company |
| K172427 | 2018-04-19 | FLL | Traditional | Avita Corporation |
| K163516 | 2017-04-21 | FLL | Special | Kaz USA, Inc., A Helen of Troy Company |
| K134043 | 2014-05-21 | FLL | Traditional | Kaz USA, Inc (A Subsidiaryof Kaz Inc) |
| K120672 | 2012-06-01 | DXN | Special | Andon Health Co., Ltd. |
| K112825 | 2012-01-18 | DXN | Traditional | Avita Corporation |
| K110559 | 2012-01-06 | FLL | Traditional | Avita Corporation |
| K102554 | 2011-03-03 | FLL | Special | Avita Corporation |
| K102624 | 2010-12-16 | DXN | Traditional | Avita Corporation |
| K090379 | 2010-05-26 | BTA | Traditional | Avita Corporation |
| K100016 | 2010-03-04 | FLL | Special | Avita Corporation |
| K092958 | 2009-12-02 | FLL | Special | Avita Corporation |
| K081160 | 2008-06-24 | FLL | Traditional | Avita Corporation |
| K072137 | 2007-12-07 | DXN | Traditional | Avita Corporation |
| K033397 | 2004-04-09 | DXN | Traditional | Avita Corporation |
| K010462 | 2001-04-11 | FLL | Traditional | Avita Corporation |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1996 |
|---|---|
| Main products | non-contact thermometer, infrared thermometer, blood pressure monitor, nebulizer, pulse oximeter |
| Certifications | GMP, FDA, CE, ISO13485 |
| OEM and ODM | Offered |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Jiangsu Likang Medical Products Co., Ltd. | 17 |
| Regent Electron Suzhou Co., Ltd. | 5 |
| JAM (Suzhou) Metal Manufacturing Co., Ltd. | 1 |
| Wujiang City Worldful Trade Co., Ltd. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.