Dongguan Mars Medical Products Co., Ltd.
Registered establishment in Dongguan, Guangdong, China. 9 device types, 1 clearance.
Dongguan Mars Medical Products Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Thermometer Kit, Bandage, Elastic and 7 other device types. Its earliest product listing with the FDA dates from 2009.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 9615583 |
| FEI number | 3003171455 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 东莞得康医疗制品有限公司 |
|---|---|
| Unified social credit code | 914419006177617236 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Dongguan |
|---|---|
| Province | Guangdong |
| Address | Room 301, 2nd Building, 6# Manfeng Industrial West Road One |
| Postal code | 523993 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Bandage, Elastic | Class 1 | 2026 | 280 | |
| Blood Pressure Cuff | Class 2 | Mars | 2019 | 50 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | Medical disposable face mask | 2020 | 182 |
| Flowmeter, Blood, Cardiovascular | Class 2 | IBD, Mars | 2009 | 4 |
| Mask, Scavenging | Class 1 | N95 Mask | 2020 | 158 |
| Respirator, Surgical | Class 2 | N95 Mask | 2020 | 118 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | Omni Original, Mars | 2009 | 98 |
| Tape And Bandage, Adhesive | Class 1 | 2026 | 353 | |
| Thermometer Kit | Class 2 | Clinical electronic thermometer,MARS-E-01 | 2021 | 11 |
Clearances
1 clearance names Dongguan Mars Medical Products Co., Ltd. as applicant. 3 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 |
|---|---|---|---|---|
| K191209 | 2019-06-18 | DXQ | Traditional | This company |
| K032825 | 2004-12-10 | DXN | Traditional | Mars Medical Products Co., Ltd. |
| K980845 | 1998-12-14 | DXN | Traditional | Mars Medical Products Co., Ltd. |
| K972213 | 1998-03-13 | DPW | Traditional | Alan S. Lee |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1975 |
|---|---|
| Main products | Medical devices, Aneroid sphygmomanometers, Medical equipment |
| Certifications | FDA |
| Export markets | Multiple countries with FDA approval |
| OEM and ODM | Offered |
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.