FDA Registration
Active
🇨🇳 China
ZIBO CHENGXUN AUTOMATIC DEVICE CO., LTD
Reg #: 3013576504
·
FEI: 3013576504
·
Expires 2025
Products
4
Proprietary Names
0
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- ZIBO CHENGXUN AUTOMATIC DEVICE CO., LTD
- Registration Number
- 3013576504
- FEI Number
- 3013576504
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 37 Minan Road, High-tech Industrial,
- City
- Zibo Shandong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K222815
Owner / Operator
- Firm Name
- Zibo Chengxun Automatic Device Co., Ltd
- Operator Number
- 10053713
- Address
- No. 37 Minan Road, High-tech Industrial,
- City
- Zibo
- State
- Shandong
- Postal Code
- 255086
- Country
- CN
- Correspondent
- Wei Ding
US Agent
- Business Name
- Omni International Corp
- Contact Name
- Ken Li
- Address
- 35 Constitution Dr Ste 1D
- City
- Bedford
- State
- NH
- ZIP
- 03110
- Country
- US
- [email protected]
- Phone
- 603 4711499
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2024-04-02 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2024-04-02 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2024-04-02 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-04-02 |
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device