Jiangxi Aicare Medical Technology Co., Ltd.
Manufacturer and brand owner in Fuzhou, Jiangxi, China. 8 device types, 3 products catalogued, 2 clearances.
Jiangxi Aicare Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Respirator, Surgical, Unit, Oral Irrigation and 6 other device types. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
8device types registered with the FDA
3products catalogued under its own name
2510(k) clearances
Registration
| Registered name | JIANGXI AICARE MEDICAL TECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016630774 |
| FEI number | 3016630774 |
| DUNS | 554530454 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 江西掌护医疗科技有限公司 |
|---|---|
| Unified social credit code | 91361025MA37Q1KHX4 |
| Source | NMPA UDI database |
Location
| City | Fuzhou |
|---|---|
| Province | Jiangxi |
| Address | No.6, South Side of Nanhuan Road Qianping Industrial Park |
| Postal code | 344300 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Clinical Electronic Thermometer | Class 2 | Infrared Forehead Thermometers A66, A68, A69 | 2025 | 49 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | Face mask | 2020 | 182 |
| Hearing Aid, Air-Conduction, Prescription | Class 1 | hearing aid | 2023 | 45 |
| Oximeter, Infrared, Sporting, Aviation | Class 2 | fingertip pulse oximeter W011; fingertip pulse oximeter W013 | 2022 | 29 |
| Respirator, Surgical | Class 2 | Face mask | 2020 | 118 |
| Sunglasses (Non-Prescription Including Photosensitive) | Class 1 | Sunglasses | 2020 | 522 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | 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 | 2022 | 98 |
| Unit, Oral Irrigation | Class 1 | Oral irrigatorWT101,WT102,WT103,WT105,WT106,WT107,WT108 | 2024 | 128 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Aile Electronic Sphygmomanometers | DXN | 7 |
| Cooceer Electronic Sphygmomanometers | DXN | 1 |
| Aile fingertip pulse oximeter | OCH | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K250185 | 2025-07-14 | DXN | Traditional | This company |
| K221040 | 2022-08-31 | DXN | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2011 |
|---|---|
| Factory area | 50,000 square meters |
| Main products | Blood glucose meters, Blood pressure monitors, Infrared thermometers, Pulse oximeters |
| Certifications | GMP |
| Export markets | Global |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Fuzhou Delphin BIO-Tech Co., Ltd. | 18 |
| Fuzhou Feiwo Trading Co., Ltd. | 11 |
| Fuzhoushi Cangshanqu Linke Maoyiyouxiangongsi | 4 |
| Fuzhou Rick Brown Biomaterials Co., Ltd. | 3 |
| Fuzhou Maixin Biotech Co., Ltd. | 3 |
| Fuzhou Xiaoyi Electronics Co., Ltd. | 2 |
| Fujian Guozi Rehabilitation Medical Co., Ltd. | 2 |
| Jiangxi Baoeran Biomedical Science & Technology Co., Ltd. | 1 |
| Fuzhou Fushunying Sports Goods Co., Ltd. | 1 |
| Fujian Yitaikang Electronics 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.