FDA Registration
Active
🇨🇳 China
JINGZHOU HAIXIN GREEN CROSS MEDICAL PRODUCTS CO.,LTD
Reg #: 3017597597
·
FEI: 3017597597
·
Expires 2026
Products
8
Proprietary Names
10
Establishment Types
3
Classifications
8
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Registration Details
- Registration Name
- JINGZHOU HAIXIN GREEN CROSS MEDICAL PRODUCTS CO.,LTD
- Registration Number
- 3017597597
- FEI Number
- 3017597597
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Yongxing North Road No.2
- City
- Jingzhou Hubei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K171535
Owner / Operator
- Firm Name
- Jingzhou Haixin Green Cross Medical Products Co.,Ltd
- Operator Number
- 10078959
- Address
- Yongxing North Road No.2
- City
- Jingzhou
- State
- Hubei
- Postal Code
- 434200
- Country
- CN
- Correspondent
- Radar Lei
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 |
|---|---|---|---|---|---|
| Gown, Isolation, Surgical | FYC | Class 2 | General, Plastic Surgery | No | 2020-11-12 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2020-11-12 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2022-11-30 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-11-12 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-11-12 |
| Suit, Surgical | FXO | Class 1 | General, Plastic Surgery | No | 2020-11-12 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2020-11-12 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2020-11-12 |
Proprietary Names
GOWN, ISOLATION, SURGICAL
Bouffant Cap
Surgical Mask (Gfm 96, Gfm 91, Gfm 90, Gfm 88, Gfm 81, Gfm 80)
Face Shield
Cover Gown; Coverall; Impervious Gown; Isolation Gown; Lab Coat; Lab Jacket; Thumbloop Gown; Non-Surgical Isolation Gown
Suit Surgical
Isolation Gown
Earloop Procedure Mask
Surgical Mask
Room
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