FDA Registration
Active
🇨🇳 China
SHANGHAI MOTEX HEALTHCARE CO., LTD.
Reg #: 9615978
·
FEI: 3003045222
·
Expires 2026
Products
4
Proprietary Names
8
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- SHANGHAI MOTEX HEALTHCARE CO., LTD.
- Registration Number
- 9615978
- FEI Number
- 3003045222
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO. 369, JIASONG ZHONG ROAD, HUAXIN, QINGPU
- City
- SHANGHAI
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K063757
Owner / Operator
- Firm Name
- SHANGHAI MOTEX HEALTHCARE CO., LTD.
- Operator Number
- 9041164
- Address
- NO. 369, JIASONG ZHONG ROAD, HUAXIN, QINGPU
- City
- SHANGHAI
- State
- CN-SH
- Postal Code
- 201708
- Country
- CN
US Agent
- Business Name
- ROC Chinese-European Industrial Research Society
- Contact Name
- Shu-Chen Cheng
- Address
- 2064 Tamarin Dr
- City
- Columbus
- State
- OH
- ZIP
- 43235
- Country
- US
- [email protected]
- Phone
- 614 5888168
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2007-11-18 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2012-05-11 |
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2007-11-18 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2022-05-30 |
Proprietary Names
Shanghai Motex
Modern Healthcare
POWDER-FREE NITRILE EXAMINATION GLOVES
Motex Powder-Free Nitrile Surgical Gloves
Nitrile Powder-Free Examination Gloves, ProBlue #7235, #7735
Motex Powdered Nitrile Surgical Gloves; Item 6010 White, 6010 Green
Motex Powder-Free Polyisoprene Sterile Surgical Gloves
Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device