Data / Medical devices / China / Roosin Medical Co., Ltd.
Roosin Medical Co., Ltd.: FDA-registered device maker in Taizhou Jiangsu, China, 6 510(k) clearances
Roosin Medical Co., Ltd. is registered with the FDA (registration 3007124979) in Taizhou Jiangsu, China. It lists 9 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 3, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3007124979
- Address
- No.8 Yuandong Road, Kouan Town Gaogang, Taizhou Jiangsu, China, 225321
- Owner or operator
- Roosin Medical Co., Ltd. (10026552)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- July 30, 2008
- Registered through
- 2026
- Brand names listed
- Absorbent pad, Amorphous Hydrogel Dressing, Burn Dressing, Burn Gel, CALCIUM ALGINATE WOUND DRESSING, Chest Seal, Copper Foam Dressing (Prescription and OTC), DEVICE, INTRAVASCULAR CATHETER SECUREMENT and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Liquid, Skin Protectant | NEC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Device, Intravascular Catheter Securement | KMK | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Holder, Ureteral Catheter | EYJ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | 1 | Exporter to the US | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | 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 |
|---|---|---|---|---|---|---|
| June 3, 2026 | K254034 | Roosin Collagen Powder | KGN | Substantially Equivalent | Roosin Medical Co., Ltd. | accessdata.fda.gov |
| June 3, 2026 | K253974 | Roosin Collagen Dressing | KGN | Substantially Equivalent | Roosin Medical Co., Ltd. | accessdata.fda.gov |
| January 11, 2024 | K231088 | Copper Foam Dressing (Prescription and OTC) | FRO | Substantially Equivalent | Roosin Medical Co., Ltd. | accessdata.fda.gov |
| November 17, 2023 | K230190 | Polyver Silver Alginate Dressing (Prescription and OTC) | FRO | Substantially Equivalent | Roosin Medical Co., Ltd. | accessdata.fda.gov |
| September 13, 2019 | K181478 | Roosin Xeroform Petrolatum Dressing | 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 Dressing, Wound, Drug
- All makers of Wound Dressing With Animal-Derived Material(S)
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- All makers of Holder, Ureteral Catheter
- All makers of System, Blood Collection, Vacuum-Assisted, Manual
- All makers of Dressing, Wound, Occlusive
Updated June 3, 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.