Data / Medical devices / China / Dragon Crown Medical Co., Ltd.
Dragon Crown Medical Co., Ltd.: FDA-registered device maker in Jinan Shandong, China, 1 510(k) clearance
Dragon Crown Medical Co., Ltd. is registered with the FDA (registration 3044905149) in Jinan Shandong, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 6, 2017. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3044905149
- Address
- 6/F, Kehui Building, No. 109 ShunHua Road, High-tech Zone No.978 Tianchen Road, High-Tech Development Zone, Jinan Shandong, China, 250101
- Owner or operator
- Dragon Crown Medical Co., Ltd. (10095414)
- Roles
- Manufacturer
- First device listed
- April 3, 2026
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Arthroscope | HRX | 2 | Manufacturer | accessdata.fda.gov |
| Cement, Bone, Vertebroplasty | NDN | 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 |
|---|---|---|---|---|---|---|
| February 6, 2017 | K162283 | DCM Kyphoplasty System | NDN | Substantially Equivalent | Dragon Crown Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 6, 2017. 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.