FDA Registration
Active
🇨🇳 China
Xiantao Zhongyi Safety & Protection Products Co.,Ltd.
Reg #: 3010141571
·
FEI: 3010141571
·
Expires 2026
Products
10
Proprietary Names
3
Establishment Types
1
Classifications
10
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Registration Details
- Registration Name
- Xiantao Zhongyi Safety & Protection Products Co.,Ltd.
- Registration Number
- 3010141571
- FEI Number
- 3010141571
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.101, Xianyuan Road
- City
- Xiantao City Hubei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K203685
Owner / Operator
- Firm Name
- Xiantao Zhongyi Safety & Protecting Products Co.,Ltd
- Operator Number
- 10042020
- Address
- No. 101, Xianyuan Road
- City
- Xiantao
- State
- Hubei
- Postal Code
- 433000
- Country
- CN
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Dr
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177 ext. 200
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2024-02-05 |
| Respirator, N95, For Use By The General Public In Public Health Medical Emergencies | NZJ | Class 2 | General Hospital | No | 2022-01-20 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2012-12-26 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2012-10-09 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2012-10-09 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2012-10-09 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2012-10-09 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2021-04-02 |
| Suit, Surgical | FXO | Class 1 | General, Plastic Surgery | No | 2012-10-09 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2012-10-09 |
Proprietary Names
Zhongyi Surgical N95 Air-purifying Flitering Facepiece Respirator (mode# ZY9501S,ZY9503S)
NIOSH N95 MASK, Model ZYB-11, ZYB-12, ZYB-13,ZYB-14 ,ZYE-02 ,ZYE-05
ZHONGYI
Establishment Types
Manufacture Medical Device