FDA Registration
Active
🇨🇳 China
Hubei Haixin Protective Products Group Co.,Ltd
Reg #: 3004158259
·
FEI: 3004158259
·
Expires 2026
Products
10
Proprietary Names
11
Establishment Types
3
Classifications
10
Registration Details
- Registration Name
- Hubei Haixin Protective Products Group Co.,Ltd
- Registration Number
- 3004158259
- FEI Number
- 3004158259
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Jinsong Avenue 8-8,Chengdong Industrial Zone
- City
- Songzi City Hubei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K123787
Owner / Operator
- Firm Name
- Hubei Haixin Protective Products Group Co.,Ltd
- Operator Number
- 9058446
- Address
- Jinsong Avenue 8-8,Chengdong Industrial Zone
- City
- Songzi
- State
- Hubei
- Postal Code
- 434205
- Country
- CN
- Correspondent
- Eric Yang
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 |
|---|---|---|---|---|---|
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2008-04-08 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2013-07-25 |
| Suit, Surgical | FXO | Class 1 | General, Plastic Surgery | No | 2011-10-18 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2006-03-13 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2008-04-08 |
| Cover, Mattress (Medical Purposes) | FMW | Class 1 | General Hospital | No | 2008-04-08 |
| Gown, Isolation, Surgical | FYC | Class 2 | General, Plastic Surgery | No | 2020-01-19 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2022-01-26 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2006-02-24 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2011-10-18 |
Proprietary Names
Cover Gown; Coverall; Impervious Gown; Isolation Gown; Lab Coat; Lab Jacket; Thumbloop Gown
Non-surgical isolation gown
Earloop Procedure Mask
Suit Surgical
Bouffant Cap
Face Shield
CPE MATTRESS COVER,PP MATTRESS COVER
AAMI 3 Fld Resist Surgical Isolation Gown
Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)
Respiratory Mask
Isolation Gown
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device