FDA Registration
Active
🇨🇳 China
ZHANGJIAGANG SHENGANG MEDICAL PRODUCTS CO.,LTD
Reg #: 3016616327
·
FEI: 3016616327
·
Expires 2026
Products
7
Proprietary Names
0
Establishment Types
3
Classifications
7
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Registration Details
- Registration Name
- ZHANGJIAGANG SHENGANG MEDICAL PRODUCTS CO.,LTD
- Registration Number
- 3016616327
- FEI Number
- 3016616327
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.388 Yongjin Road,, Tangqiao Town
- City
- Zhangjiagang Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K082863
Owner / Operator
- Firm Name
- Zhangjiagang Shengang Medical Products Co.,Ltd
- Operator Number
- 10063070
- Address
- Xican North Road, Xican Village, Fenghuang Town
- City
- Zhangjiagang
- State
- CN-NOTA
- Postal Code
- 215614
- Country
- CN
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2022-03-07 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2022-03-07 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | Class 1 | Gastroenterology, Urology | No | 2020-06-24 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-03-16 |
| Patient Examination Glove | FMC | Class 1 | General Hospital | No | 2021-03-31 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-23 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-04-10 |
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)