FDA Registration
Active
🇨🇳 China
Sinolinks Medical Innovation, Inc.
Reg #: 3008383115
·
FEI: 3008383115
·
Expires 2026
Products
5
Proprietary Names
10
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- Sinolinks Medical Innovation, Inc.
- Registration Number
- 3008383115
- FEI Number
- 3008383115
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO.10 Ziwei Road, Zhonglou Zone
- City
- ChangZhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K250820
Owner / Operator
- Firm Name
- Sinolinks Medical Innovation, Inc.
- Operator Number
- 10032341
- Address
- NO.10 Ziwei Road, Zhonglou Zone
- City
- ChangZhou
- State
- Jiangsu
- Postal Code
- 213032
- Country
- CN
- Correspondent
- Juan Zhao
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2025-07-15 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2024-07-03 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2015-10-08 |
| Stapler, Skin | QQS | Class 1 | General Hospital | No | 2024-05-26 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2025-02-16 |
Proprietary Names
Disposable Trocars
Disposable Skin Staple removers
Disposable Circular Stapler
Disposable Linear Staplers and Reloads
Disposable Linear Cutter Staplers and Reloads
Disposable Endoscopic Linear Cutter Staplers and Reloads
Disposable Curved Cutter Stapler
Disposable Hemorrhoidal Stapler
Disposable Skin Stapler
Applier
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device