Zhuhai DR Medical Instruments Co., Ltd.
Registered establishment in Zhuhai, Guangdong, China. 4 device types, 2 clearances.
Zhuhai DR Medical Instruments Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Syringe, Antistick, Clamp And Cutter, Umbilical and 2 other device types. Its earliest product listing with the FDA dates from 2021.
4device types registered with the FDA
2510(k) clearances
Registration
| Registered name | ZHUHAI DR MEDICAL INSTRUMENTS CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3020298301 |
| FEI number | 3020298301 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 珠海德瑞医疗器械有限公司 |
|---|---|
| Unified social credit code | 91440400MA4UM570XD |
| Source | provincial manufacturer licence lists |
Location
| City | Zhuhai |
|---|---|
| Province | Guangdong |
| Address | No. 352, Dingwansan Road, Jinwan District, Zhuhai, Guangdong Province, P.R. China |
| Postal code | 519000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Clamp And Cutter, Umbilical | Class 2 | 2021 | 4 | |
| Injector And Syringe, Angiographic | Class 2 | Extension tube | 2026 | 15 |
| Needle, Hypodermic, Single Lumen | Class 2 | safety syringe | 2021 | 71 |
| Syringe, Antistick | Class 2 | safety syringe | 2021 | 39 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K251788 | 2026-03-05 | DXT | Traditional | This company |
| K212226 | 2021-09-29 | MEG | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2016 |
|---|---|
| Factory area | 40,000 sqm |
| Main products | Infusion connectors and accessories, Passive hemostasis devices, Compression elastic bandages, Umbilical cord clamps, Bone cement kits |
| Certifications | National High-tech Enterprise, Provincial and municipal specialized and sophisticated enterprise |
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.