FDA Registration
Active
🇨🇳 China
SHANDONG HENGYA PACKAGING PRINTING CO.,LTD
Reg #: 3015412466
·
FEI: 3015412466
·
Expires 2025
Products
4
Proprietary Names
0
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- SHANDONG HENGYA PACKAGING PRINTING CO.,LTD
- Registration Number
- 3015412466
- FEI Number
- 3015412466
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Hetou village, Yingqiu town, Changle county,
- City
- Weifang Shandong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K222815
Owner / Operator
- Firm Name
- Shandong Hengya Packaging Printing Co.,Ltd
- Operator Number
- 10060268
- Address
- Hetou village, Yingqiu town, Changle county,
- City
- Weifang
- State
- Shandong
- Postal Code
- 262416
- Country
- CN
- Correspondent
- Sunny Hu
US Agent
- Business Name
- Omni International Corp
- Contact Name
- Renee Rees
- Address
- 35 Constitution Drive, Suite 1D
- City
- Bedford
- State
- NH
- ZIP
- 03110
- Country
- US
- [email protected]
- Phone
- 603 4171499 ext. 201
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2024-09-17 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-09-17 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2024-09-17 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2024-09-17 |
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device