Suzhou Melodicare Medical Technology Co., Ltd.
Registered establishment in Suzhou, Jiangsu, China. 3 device types, 1 clearance.
Suzhou Melodicare Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Mask, Surgical, Stethoscope, Electronic and 1 other device type. Its earliest product listing with the FDA dates from 2020.
Registration
| Registered name | SUZHOU MELODICARE MEDICAL TECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016864576 |
| FEI number | 3016864576 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 苏州美糯爱医疗科技有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | Room 301, Building F2, No. 32 Hongxi road, Suzhou high-tech zone,Jiangsu province. |
| Postal code | 215000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Continuous Measurement Thermometer | Class 2 | Infrared Thermometer, model Breeze, Infrared Thermometer, model Breeze-20 | 2020 | 115 |
| Mask, Surgical | Class 2 | Surgical Mask | 2020 | 125 |
| Stethoscope, Electronic | Class 2 | Electronic Stethoscope,model:smartho-D2, Electronic Stethoscope,model:iSteso-D2 | 2021 | 3 |
Clearances
1 clearance names Suzhou Melodicare Medical Technology Co., Ltd. as applicant. 2 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 |
|---|---|---|---|---|
| K191283 | 2019-10-18 | FLL | Traditional | This company |
| K191667 | 2019-12-18 | DQD | Traditional | Hefei Mintti Medical Technology Co., Ltd. China |
| K770463 | 1977-03-23 | FXX | Traditional | Precept, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Intelligent stethoscopes, ECG devices, Digital thermometers, Multi-parameter monitors |
|---|
Nearby Manufacturers
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.