Data / Medical devices / China / Qingdao Bright Moon Biomedical Materials Co Ltd
Qingdao Bright Moon Biomedical Materials Co Ltd: FDA-registered device maker in Qingdao Shandong, China, 2 510(k) clearances
Qingdao Bright Moon Biomedical Materials Co Ltd is registered with the FDA (registration 3011210302) in Qingdao Shandong, China. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 19, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011210302
- Address
- No.788 Mingyue Road,Huangdao Qingdao,China, Qingdao Shandong, China, 266400
- Owner or operator
- Qingdao Bright Moon Biomedical Materials Co Ltd (10047260)
- Roles
- Manufacturer
- First device listed
- July 29, 2014
- Registered through
- 2026
- Brand names listed
- Algitocare CMC wound dressing/Gelling fiber dressing, Algitocare alginate bandages/Alginate bandages, Algitocare alginate wound dressing/ Alginate wound dressing/Calium Alginate Dressing, Algitocare hydrogel wound dressing/Hydrogel wound dressing, Algitocare silicone foam dressing/Silicone foam dressing, Algitocare silicone gel sheet/ gel sheet/silicone gel, Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription), Hydrocolloid wound dressing/Algitocare hydrocolloid dressing and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Elastic | FQM | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Manufacturer | accessdata.fda.gov |
| Elastomer, Silicone, For Scar Management | MDA | 1 | 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 |
|---|---|---|---|---|---|---|
| December 19, 2025 | K252167 | Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) | FRO | Substantially Equivalent | Qingdao Bright Moon Biomedical Materials Co., Ltd. | accessdata.fda.gov |
| March 16, 2023 | K220673 | Sterile Silver Alginate Wound Dressing | FRO | Substantially Equivalent | Qingdao Bright Moon Biomedical Materials Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Drug
- All makers of Elastomer, Silicone, For Scar Management
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- All makers of Bandage, Elastic
- All makers of Dressing, Wound, Hydrophilic
- All makers of Dressing, Wound, Occlusive
Updated December 19, 2025. 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.