FDA Registration
Active
🇨🇳 China
AVITA (WUJIANG) CO., LTD
Reg #: 3004727197
·
FEI: 3004727197
·
Expires 2026
Products
15
Proprietary Names
17
Establishment Types
2
Classifications
15
Registration Details
- Registration Name
- AVITA (WUJIANG) CO., LTD
- Registration Number
- 3004727197
- FEI Number
- 3004727197
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.858.Jiao Tong Road, Wujiang Economic Development Zone
- City
- Wujiang City Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K181242
Owner / Operator
- Firm Name
- AViTA (WUJIANG) CO., LTD
- Operator Number
- 9066962
- Address
- No.858.Jiao Tong Road, Wujiang Economic Development Zone
- City
- Wujiang City, Jiangsu, CHINA
- State
- CN-NOTA
- Postal Code
- 215200
- Country
- CN
- Correspondent
- Rex Hsieh
US Agent
- Business Name
- Compliance Engineering, Inc
- Contact Name
- Ken Grant
- Address
- 2611 Merrick Rd #66 Bellmore , NY US
- City
- Bellmore
- State
- NY
- ZIP
- 11710
- Country
- US
- [email protected]
- Phone
- 516 9847287
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2018-07-31 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2012-02-07 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2024-09-12 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2026-04-16 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2021-08-23 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2008-01-11 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2024-11-08 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2025-12-04 |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | Class 2 | General, Plastic Surgery | No | 2020-05-28 |
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2025-07-14 |
| Irrigator, Powered Nasal | KMA | Class 1 | Ear, Nose, Throat | No | 2005-09-02 |
| Humidifier Nebulizer Kit | OGG | Class 2 | Anesthesiology | No | 2023-12-22 |
| Detectors And Removers, Lice, (Including Combs) | LJL | Class 1 | General Hospital | No | 2014-12-10 |
| Oximeter, Infrared, Sporting, Aviation | OCH | Class 2 | Cardiovascular | No | 2023-06-28 |
| Breast Pump Kit | OHH | Class 2 | Obstetrics/Gynecology | No | 2023-07-28 |
Proprietary Names
BRAUN Sensian 4 3-in-1 Thermometer BNT100USV2
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)
Arm Type Blood Pressure Monitor (BPM82)
BRAUN THERMOSCAN 3 EAR THERMOMETER IRT3030USV2
BRAUN THERMOSCAN 4 EAR THERMOMETER IRT3515USV2
NS22
AViTA Nasal Aspirator NS13
BN005
AViTA Nasal Aspirator NS24
BN007
LC10
AViTA Pulse Oximeter (SP61)
AViTA Breast Pump BR10
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)