FDA Registration
Active
🇨🇳 China
Roosin Medical Co., Ltd.
Reg #: 3007124979
·
FEI: 3007124979
·
Expires 2026
Products
9
Proprietary Names
31
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- Roosin Medical Co., Ltd.
- Registration Number
- 3007124979
- FEI Number
- 3007124979
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.8 Yuandong Road, Kouan Town, Gaogang
- City
- Taizhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K253974
Owner / Operator
- Firm Name
- Roosin Medical Co., Ltd.
- Operator Number
- 10026552
- Address
- No.8 Yuandong Road, Kouan Town, Gaogang
- City
- Taizhou
- State
- Jiangsu
- Postal Code
- 225321
- Country
- CN
US Agent
- Business Name
- Manton Business and Technology Services
- Contact Name
- Charles Shen
- Address
- 37 Winding Rdg
- City
- Oakland
- State
- NJ
- ZIP
- 07436
- Country
- US
- [email protected]
- Phone
- 608 2179358
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2026-06-04 |
| Holder, Ureteral Catheter | EYJ | Class 1 | Gastroenterology, Urology | No | 2024-11-13 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2008-07-30 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2023-11-18 |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | Class 1 | Hematology | No | 2025-02-26 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2013-10-23 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2011-10-13 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2011-10-13 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2024-11-13 |
Proprietary Names
Roosin Collagen Dressing
HOLDER, URETERAL CATHETER
CALCIUM ALGINATE WOUND DRESSING
HYDROCOLLOID DRESSING
ISLAND DRESSING
GELLING FIBER DRESSING
Polyver Silver Alginate Dressing (Prescription and OTC)
PRP
Vacuum Tube-PRF
Hydrocolloid Dressing
Roosin Xeroform Petrolatum Dressing
Roosin Silver Alginate Dressing
Copper Foam Dressing (Prescription and OTC)
Hydrogel sheet wound dressing
Amorphous Hydrogel Dressing
Hydrogel Medical Dressing
Hydrogel Gauze
Burn Dressing
Burn Gel
Roosin Collagen Powder
Petrolatum dressing
Foam Dressing
Oil Emulsion dressing
Silicone Foam Dressing
Honey Gauze Dressing, Honey Calcium Alginate Dressing, Honey Gel
Transparent dressing
Chest Seal
Paraffin gauze dressing
Super absorbent pad
Absorbent pad
DEVICE, INTRAVASCULAR CATHETER SECUREMENT
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)