FDA Registration
Active
🇨🇳 China
ZHENGZHOU WECARE GLOVE CO., LTD.
Reg #: 3015223936
·
FEI: 3015223936
·
Expires 2026
Products
1
Proprietary Names
4
Establishment Types
2
Classifications
1
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Registration Details
- Registration Name
- ZHENGZHOU WECARE GLOVE CO., LTD.
- Registration Number
- 3015223936
- FEI Number
- 3015223936
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.18 Dongfeng Road
- City
- Zhengzhou Henan
- Country
- CN
Owner / Operator
- Firm Name
- ZHENGZHOU WECARE GLOVE CO., LTD.
- Operator Number
- 10094540
- Address
- No.18 Dongfeng Road
- City
- Zhengzhou
- State
- Henan
- Postal Code
- 450000
- Country
- CN
- Correspondent
- Karen Li
US Agent
- Business Name
- AOKT STUDIO LLC
- Contact Name
- Aokai Tang
- Address
- 105 W WELLING AVE
- City
- Pennington
- State
- NJ
- ZIP
- 08534
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2025-12-05 |
Proprietary Names
WE01, WE02, WE03,WE05,WE06,WE07,WE08,WE09,WE10,WE11,WE12,WE15,WE16,WE17,WE18,WE19,WE20,WE21,WE22,WE23,WE24,WE25,WE26
CLASS I MEDICAL DEVICES(GLOVES, BRACES AND SUPPORTS)
WE27,WE28,WE29,WE50,WE51,WE52,WE53,WE54,WE55,WE56,WE57,WE58,WE59,WE60,WE61,WE62,WE63,WE64,WE65,WE66,WE67,WE68,WE69
WE70,WE71,WE72,WE76
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device