Roosin Medical Co., Ltd.
Taizhou Jiangsu, CN
Roosin Medical Co., Ltd. appears in FDA device records in Taizhou Jiangsu, CN. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Roosin Medical Co., Ltd. between 2019 and 2026. The busiest year on record is 2026, with 2. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254034 | Roosin Collagen Powder | KGN | Substantially Equivalent | |
| K253974 | Roosin Collagen Dressing | KGN | Substantially Equivalent | |
| K231088 | Copper Foam Dressing (Prescription and OTC) | FRO | Substantially Equivalent | |
| K230190 | Polyver Silver Alginate Dressing (Prescription and OTC) | FRO | Substantially Equivalent | |
| K181478 | Roosin Xeroform Petrolatum Dressing | FRO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007124979 | 3007124979 | Roosin Medical Co., Ltd. | No.8 Yuandong Road, Kouan Town, Taizhou Jiangsu 225321 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NECBandage, Liquid, Skin Protectant
- KMKDevice, Intravascular Catheter Securement
- FRODressing, Wound, Drug
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic
- NACDressing, Wound, Hydrophilic
- NADDressing, Wound, Occlusive
- EYJHolder, Ureteral Catheter
- KSTSystem, Blood Collection, Vacuum-Assisted, Manual
- KGNWound Dressing With Animal-Derived Material(S)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain