FDA Registration
Active
🇨🇳 China
XINGYU MEDICAL TECH CO.,LTD
Reg #: 3018779144
·
FEI: 3018779144
·
Expires 2026
Products
4
Proprietary Names
6
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- XINGYU MEDICAL TECH CO.,LTD
- Registration Number
- 3018779144
- FEI Number
- 3018779144
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.2189 Yaoqian Road, Gaomi Economic Development Zone,
- City
- Weifang City Shandong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K240629
Owner / Operator
- Firm Name
- Xingyu Medical Tech Co.,Ltd
- Operator Number
- 10081106
- Address
- No.2189 Yaoqian Road, Gaomi Economic Development Zone,
- City
- Weifang City
- State
- Shandong
- Postal Code
- 261500
- Country
- CN
- Correspondent
- Chongyu Xu
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 | 2021-03-17 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2024-08-14 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-08-14 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2024-08-14 |
Proprietary Names
Xingyu Powder Free Nitrile Patient Examination Gloves, Blue Color
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
Nitrile Disposable Examination Gloves-510K
Xingyu Nitrile Powder Free Patient Examination Gloves, White Color
Nitrile Disposable Examination Gloves
Nitrile Disposable Examination Gloves (Tested For Use With Chemotherapy Drugs)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device