Data / Medical devices / China / Zhuhai Dipu Medical Technology Co., Ltd.
Zhuhai Dipu Medical Technology Co., Ltd.: FDA-registered device maker in Zhuhai Guangdong, China, 2 510(k) clearances
Zhuhai Dipu Medical Technology Co., Ltd. is registered with the FDA (registration 3031594238) in Zhuhai Guangdong, China. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 26, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031594238
- Address
- 1F, Building 13, GMP Production Workshop, Zhuhai International Health Harbor, No. 628 Airport West Road Sanzao Town, Jinwan District, Zhuhai Guangdong, China, 519040
- Owner or operator
- Zhuhai Dipu Medical Technology Co., Ltd. (10089377)
- Roles
- Manufacturer
- First device listed
- June 17, 2024
- Registered through
- 2026
- Brand names listed
- DPM, 3D Endoscopic Fluorescence Camera System,DPM-ENDOCAM-06PF, DPM, Endoscopic Fluorescence Camera System, DPM-ENDOCAM-03PF
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| System, Surgical, Computer Controlled Instrument | NAY | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Angiographic | IZI | 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 |
|---|---|---|---|---|---|---|
| June 26, 2024 | K233840 | Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF) | GCJ | Substantially Equivalent | Zhuhai Dipu Medical Technology Co., Ltd. | accessdata.fda.gov |
| June 13, 2024 | K233892 | 3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF) | GCJ | Substantially Equivalent | Zhuhai Dipu Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Laparoscope, General & Plastic Surgery
- All makers of System, X-Ray, Angiographic
- All makers of System, Surgical, Computer Controlled Instrument
Updated June 26, 2024. 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.