FDA Registration
Active
🇨🇳 China
Shanghai INT Medical Instruments Co., Ltd.
Reg #: 3009605245
·
FEI: 3009605245
·
Expires 2026
Products
9
Proprietary Names
8
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- Shanghai INT Medical Instruments Co., Ltd.
- Registration Number
- 3009605245
- FEI Number
- 3009605245
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 925 Jinyuan Yi Road
- City
- Shanghai
- Country
- CN
Owner / Operator
- Firm Name
- Shanghai INT Medical Instruments Co., Ltd.
- Operator Number
- 10051494
- Address
- 925 Jinyuan Yi Road
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 201803
- Country
- CN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Angiography/Angioplasty Kit | OEQ | Class 2 | Cardiovascular | No | 2020-11-03 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2016-03-25 |
| Tourniquet, Pneumatic | KCY | Class 1 | General, Plastic Surgery | No | 2024-06-18 |
| Trocar | DRC | Class 2 | Cardiovascular | No | 2018-10-31 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2017-04-18 |
| Percutaneous Sheath Introducer Kit | OFL | Class 2 | Cardiovascular | No | 2021-06-09 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2026-02-24 |
| Wire, Guide, Catheter, Exempt | PTL | Class 2 | Cardiovascular | No | 2024-02-28 |
| Syringe, Balloon Inflation, Exempt | PTM | Class 2 | Cardiovascular | No | 2017-07-26 |
Proprietary Names
Stopcock, Manifold, Y-Connector Pack YCK119B.
TOURNIQUET, PNEUMATIC
KDL Introducer Needle
KDL Mini Introducer Kit, INT® Mini Introducer Kit
INT® Torque Device YCK122
Guidewire Torquer, INT® Torque Device
Inflation Device AI25, AI25A, AI30, AI40, ID30, INT® Digitalgauge Inflation Device INT-IDA-233.
Digitalgauge Inflation Device, INT® Digitalgauge Inflation Device
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)