Data / Medical devices / China / Zhuhai DR Medical Instruments Co., Ltd.
Zhuhai DR Medical Instruments Co., Ltd.: FDA-registered device maker in Zhuhai Guangdong, China, 2 510(k) clearances
Zhuhai DR Medical Instruments Co., Ltd. is registered with the FDA (registration 3020298301) in Zhuhai Guangdong, China. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 5, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020298301
- Address
- No. 352, Dingwansan Road, Jinwan District, Zhuhai, Guangdong Province, P.R. China, Zhuhai Guangdong, China, 519000
- Owner or operator
- Zhuhai DR Medical Instruments Co., Ltd. (10082359)
- Roles
- Manufacturer
- First device listed
- July 15, 2021
- Registered through
- 2026
- Brand names listed
- Extension tube, safety syringe
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clamp And Cutter, Umbilical | NBZ | 2 | Manufacturer | accessdata.fda.gov |
| Injector And Syringe, Angiographic | DXT | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 5, 2026 | K251788 | Extension tube | DXT | Substantially Equivalent | Zhuhai DR Medical Instruments Co., Ltd. | accessdata.fda.gov |
| September 29, 2021 | K212226 | DR Safety Syringe, Sterile Hypodermic needle for Single use | MEG | Substantially Equivalent | Zhuhai DR Medical Instruments Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Clamp And Cutter, Umbilical
- All makers of Injector And Syringe, Angiographic
- All makers of Syringe, Antistick
- All makers of Needle, Hypodermic, Single Lumen
Updated March 5, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.