Polyzon Sciences Co., Ltd.
Registered establishment in Shanghai, China. 12 device types.
Polyzon Sciences Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Mask, Scavenging, Non-Surgical Gown and 10 other device types. Its earliest product listing with the FDA dates from 2016.
Registration
| Registered name | POLYZON SCIENCES Co., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3012629741 |
| FEI number | 3012629741 |
| Establishment type | Contract manufacturer, Specification developer, Private-label distributor, Manufacturer, Exporter |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | 604B, #69, 1688 NORTH GUOQUAN ROAD |
| Postal code | 200433 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Isolation Mask | 2020 | 439 |
| Device, Intravascular Catheter Securement | Class 1 | Device,intravascular Catheter Securement | 2024 | 33 |
| Dressing, Wound, Drug | Class U | Silver Alginate Dressing, Polyver Silver Alginate Dressing (Prescription and OTC) | 2021 | 48 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | Sterile Burn Dressing, Hydrogel Medical Dressing, Hydrogel Gauze, Amorphous Hydrogel Dressing | 2016 | 118 |
| Dressing, Wound, Hydrophilic | Class 1 | Calcium Alginate Wound Dressings, Island Dressing, Cover Dressing, Calcium Alginate Wound Dressing, Honey Calcium Alginate Dressing, Hydrocolloid Dressing and 1 more | 2016 | 195 |
| Dressing, Wound, Occlusive | Class 1 | Foam Dressing, Honey Gauze Dressing, Transparent dressing, Waterproof Composite Dressing, Silicone Foam Dressing, Super Absorbent Dressing and 7 more | 2016 | 183 |
| Elastomer, Silicone, For Scar Management | Class 1 | Silicone Dressing scarcinpad | 2021 | 85 |
| First Aid Kit Without Drug | Class 1 | Kit | 2024 | 132 |
| Holder, Ureteral Catheter | Class 1 | Holder,ureteral Catheter | 2024 | 29 |
| Mask, Scavenging | Class 1 | Isolation Mask | 2020 | 158 |
| Non-Surgical Gown | Class 1 | NON-Surgical Isolation Gown | 2020 | 318 |
| Tape And Bandage, Adhesive | Class 1 | NON-Woventape | 2021 | 353 |
Clearances
No clearance names Polyzon Sciences Co., Ltd. as applicant. 2 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K230190 | 2023-11-17 | FRO | Traditional | Roosin Medical Co., Ltd. |
| K143335 | 2015-06-01 | FRO | Traditional | Roosin Medical Devices Co., Ltd. |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.