Roosin Medical Co., Ltd.
Manufacturer and brand owner in Taizhou, Jiangsu, China. 9 device types, 20 products catalogued, 5 clearances.
Roosin Medical Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Dressing, Wound, Drug, Holder, Ureteral Catheter and 7 other device types. 14 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2008.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3007124979 |
| FEI number | 3007124979 |
| DUNS | 527587815 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Location
| City | Taizhou |
|---|---|
| Province | Jiangsu |
| Address | No.8 Yuandong Road, Kouan Town |
| Postal code | 225321 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Bandage, Liquid, Skin Protectant | Class 1 | Hydrocolloid Dressing | 2013 | 41 |
| Device, Intravascular Catheter Securement | Class 1 | Device, Intravascular Catheter Securement | 2024 | 33 |
| Dressing, Wound, Drug | Class U | Roosin Silver Alginate Dressing, Roosin Xeroform Petrolatum Dressing, Copper Foam Dressing (Prescription and OTC), Polyver Silver Alginate Dressing (Prescription and OTC) | 2015 | 48 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | Hydrogel Gauze, Hydrogel Medical Dressing, Amorphous Hydrogel Dressing, Burn Dressing, Hydrogel sheet wound dressing, Burn Gel | 2011 | 118 |
| Dressing, Wound, Hydrophilic | Class 1 | Hydrocolloid Dressing, Calcium Alginate Wound Dressing, Island Dressing, Gelling Fiber Dressing | 2008 | 195 |
| Dressing, Wound, Occlusive | Class 1 | Oil Emulsion dressing, Foam Dressing, Petrolatum dressing, Silicone Foam Dressing, Honey Gauze Dressing, Honey Calcium Alginate Dressing, Honey Gel, Transparent dressing and 4 more | 2011 | 183 |
| Holder, Ureteral Catheter | Class 1 | Holder, Ureteral Catheter | 2024 | 29 |
| System, Blood Collection, Vacuum-Assisted, Manual | Class 1 | Vacuum Tube-PRF, PRP | 2025 | 31 |
| Wound Dressing With Animal-Derived Material(S) | Class U | Roosin Collagen Dressing, Roosin Collagen Powder | 2026 | 12 |
Own-Brand Listings
Clearances
5 clearances name Roosin Medical Co., Ltd. as applicant. 1 is held by another company 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 |
|---|---|---|---|---|
| K254034 | 2026-06-03 | KGN | Traditional | This company |
| K253974 | 2026-06-03 | KGN | Traditional | This company |
| K231088 | 2024-01-11 | FRO | Traditional | This company |
| K230190 | 2023-11-17 | FRO | Traditional | This company |
| K181478 | 2019-09-13 | FRO | Traditional | This company |
| K143335 | 2015-06-01 | FRO | Traditional | Roosin Medical Devices Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1996 |
|---|---|
| Employees | 120 |
| Factory area | 10,000 square meters |
| Main products | calcium alginate dressing, hydrocolloid dressing, paraffin gauze, burn gel, hydrogel dressing |
| Certifications | ISO 13485, FDA, CE |
| Export markets | US 40%, Europe 30%, Other 30% |
| OEM and ODM | Offered |
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.