FDA Registration
Active
🇨🇳 China
Disposable Endoscope Valves Set A
Reg #: 3009064553
·
FEI: 3009064553
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHANGHAI HEYI MEDICAL INSTRUMENTS CO., LTD.
- Registration Number
- 3009064553
- FEI Number
- 3009064553
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 25D, HEYI BUSINESS PLAZA, NO. 420 JIANGNING RD.,JINGAN
- City
- SHANGHAI
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K151714
Owner / Operator
- Firm Name
- SHANGHAI HEYI MEDICAL INSTRUMENTS CO., LTD.
- Operator Number
- 10056224
- Address
- 25D, HEYI BUSINESS PLAZA, NO. 420 JIANGNING RD.,JINGAN
- City
- SHANGHAI
- State
- CN-SH
- Postal Code
- 200041
- Country
- CN
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr.
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoscope Channel Accessory | ODC | Class 2 | Gastroenterology, Urology | No | 2017-11-16 |
Proprietary Names
Disposable Endoscope Valves Set A
Establishment Types
Export Device to the United States But Perform No Other Operation on Device