FDA Registration
Active
🇨🇳 China
JIANGXI AICARE MEDICAL TECHNOLOGY CO., LTD
Reg #: 3016630774
·
FEI: 3016630774
·
Expires 2026
Products
8
Proprietary Names
8
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- JIANGXI AICARE MEDICAL TECHNOLOGY CO., LTD
- Registration Number
- 3016630774
- FEI Number
- 3016630774
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.6, South Side of Nanhuan Road Qianping Industrial Park, Le'an County
- City
- Fuzhou Jiangxi
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K250185
Owner / Operator
- Firm Name
- Jiangxi AICARE Medical Technology Co., Ltd
- Operator Number
- 10065465
- Address
- No.6, South Side of Nanhuan Road Qianping Industrial Park,, Le'an County
- City
- Fuzhou
- State
- Jiangxi
- Postal Code
- 344300
- Country
- CN
- Correspondent
- Lizhu Xiao
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | Class 1 | Ophthalmic | No | 2020-05-15 |
| Oximeter, Infrared, Sporting, Aviation | OCH | Class 2 | Cardiovascular | No | 2022-12-07 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-03-29 |
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2024-04-16 |
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2023-05-05 |
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2025-07-21 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2025-07-21 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-04-17 |
Proprietary Names
Sunglasses
fingertip pulse oximeter W011; fingertip pulse oximeter W013
Face mask
Oral irrigatorWT101,WT102,WT103,WT105,WT106,WT107,WT108
hearing aid
Infrared Forehead Thermometers A66, A68, A69
Electronic Sphygmomanometers ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24
Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device