FDA Registration
Active
🇨🇳 China
SHANDONG INT MEDICAL INSTRUMENTS CO., LTD
Reg #: 3034544377
·
FEI: 3034544377
·
Expires 2026
Products
4
Proprietary Names
6
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- SHANDONG INT MEDICAL INSTRUMENTS CO., LTD
- Registration Number
- 3034544377
- FEI Number
- 3034544377
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 188, Fuzhou Road, Rizhao city, Shandong, China.
- City
- Rizhao Shandong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K242143
Owner / Operator
- Firm Name
- Shandong INT Medical Instruments Co., Ltd
- Operator Number
- 10091928
- Address
- No. 188, Fuzhou Road, Rizhao city, Shandong, China.
- City
- Rizhao
- State
- Shandong
- Postal Code
- 276803
- Country
- CN
- Correspondent
- Jeffrey Hui
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Balloon Inflation, Exempt | PTM | Class 2 | Cardiovascular | No | 2025-09-02 |
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2025-01-13 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2024-12-08 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2025-09-02 |
Proprietary Names
Inflation Device
Angiography Injector
Pressure Bandage
High Pressure Tubing
Stopcock
Manifold
Establishment Types
Manufacture Medical Device