FDA Registration
Active
🇨🇳 China
Gown
Reg #: 9680357
·
FEI: 3004829691
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY
- Registration Number
- 9680357
- FEI Number
- 3004829691
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 17, Banhu Rd, Huang Jiang Town,
- City
- DONG GUAN CITY Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K964142
Owner / Operator
- Firm Name
- DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY
- Operator Number
- 9008465
- Address
- BAN HU INDUSTRIAL DISTRICT, Huang Jiang Town
- City
- Dongguan,
- State
- Guangdong
- Postal Code
- 523753
- Country
- CN
- Correspondent
- SHERRY - HUANG
US Agent
- Business Name
- MAYTEX CORP.
- Contact Name
- GARY WANG
- Address
- 23521 FOLEY ST.
- City
- HAYWARD
- State
- CA
- ZIP
- 94545
- Country
- US
- [email protected]
- Phone
- 510 8874888 ext. 0
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2017-02-21 |
Proprietary Names
Gown
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device for Another Party (Contract Manufacturer)