FDA Registration
Active
🇨🇳 China
SHANDONG HYSURE SAFETY TECH CO., LTD
Reg #: 3031180726
·
FEI: 3031180726
·
Expires 2026
Products
4
Proprietary Names
2
Establishment Types
2
Classifications
4
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Registration Details
- Registration Name
- SHANDONG HYSURE SAFETY TECH CO., LTD
- Registration Number
- 3031180726
- FEI Number
- 3031180726
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 1201, Building 1, Heping Square, No. 3555 Heping Road
- City
- Weifang City Shandong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K212735
Owner / Operator
- Firm Name
- Shandong Hysure Safety Tech Co., Ltd
- Operator Number
- 10090339
- Address
- Room 1201, Building 1, Heping Square, No. 3555 Heping Road
- City
- Weifang City
- State
- Shandong
- Postal Code
- 261021
- Country
- CN
- Correspondent
- Carrie Li
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2024-03-14 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-03-14 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2026-01-21 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2026-01-21 |
Proprietary Names
polymer patient examination glove
Nitrile Disposable Examination Gloves, Tested forUse with Chemotherapy Drugs and Fentanyl
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device