Data / Medical devices / China / Beijing Kreate Medical Co., Ltd.
Beijing Kreate Medical Co., Ltd.: FDA-registered device maker in Beijing, China, 3 510(k) clearances
Beijing Kreate Medical Co., Ltd. is registered with the FDA (registration 3038550164) in Beijing, China. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 14, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038550164
- Address
- C306, West Ring South Road #18, E-town, Beijing, China, 100023
- Owner or operator
- Beijing Kreate Medical Co., Ltd. (10095208)
- Roles
- Manufacturer
- First device listed
- February 5, 2026
- Registered through
- 2026
- Brand names listed
- Redermax Antibacterial Wound Matrix, Redermo Wound Matrix, SurCura Antibacterial Wound Matrix, SurCura Wound Matrix
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorbable Synthetic Wound Dressing | QSZ | U | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | 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 |
|---|---|---|---|---|---|---|
| August 14, 2026 | K261646 | Redermax® Antibacterial Wound Matrix | FRO | Substantially Equivalent | Beijing Kreate Medical Co., Ltd. | accessdata.fda.gov |
| April 16, 2026 | K260020 | Redermo Wound Matrix | QSZ | Substantially Equivalent | Beijing Kreate Medical Co., Ltd. | accessdata.fda.gov |
| February 2, 2026 | K251582 | Redermax Antibacterial Wound Matrix | FRO | Substantially Equivalent | Beijing Kreate Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 14, 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.