Data / Medical devices / China / POLYZON SCIENCES Co., LTD
POLYZON SCIENCES Co., LTD: FDA-registered device maker in Shanghai, China, 2 510(k) clearances
POLYZON SCIENCES Co., LTD is registered with the FDA (registration 3012629741) in Shanghai, China. It lists 12 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 17, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012629741
- Address
- 604B, #69, 1688 North Guoquan Road Yangpu District, Shanghai, China, 200433
- Owner or operator
- POLYZON SCIENCES Co., Ltd (10051970)
- Roles
- Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Specification developer
- First device listed
- May 25, 2016
- Registered through
- 2026
- Brand names listed
- Amorphous Hydrogel Dressing, BORDERED GAUZE DRESSING, CALCIUM ALGINATE WOUND DRESSING, COVER DRESSING, Calcium Alginate Wound Dressings, DEVICE ,INTRAVASCULAR CATHETER SECUREMENT, Foam Dressing, HOLDER ,URETERAL CATHETER and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Exporter to the US | accessdata.fda.gov |
| Device, Intravascular Catheter Securement | KMK | 1 | Exporter to the US | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Exporter to the US | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Exporter to the US | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Exporter to the US | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Exporter to the US | accessdata.fda.gov |
| Elastomer, Silicone, For Scar Management | MDA | 1 | Exporter to the US | accessdata.fda.gov |
| First Aid Kit Without Drug | OHO | 1 | Exporter to the US | accessdata.fda.gov |
| Holder, Ureteral Catheter | EYJ | 1 | Exporter to the US | accessdata.fda.gov |
| Mask, Scavenging | KHA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Foreign private label distributor, Manufacturer, Specification developer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| November 17, 2023 | K230190 | Polyver Silver Alginate Dressing (Prescription and OTC) | FRO | Substantially Equivalent | Roosin Medical Co., Ltd. | accessdata.fda.gov |
| June 1, 2015 | K143335 | Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC) | FRO | Substantially Equivalent | Roosin Medical Devices Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessory, Surgical Apparel
- All makers of Mask, Scavenging
- All makers of Tape And Bandage, Adhesive
- All makers of First Aid Kit Without Drug
- All makers of Device, Intravascular Catheter Securement
- All makers of Dressing, Wound, Hydrophilic
Updated November 17, 2023. 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.