Jingzhou Haixin Green Cross Medical Products Co., Ltd.
Registered establishment in Jingzhou, Hubei, China. 8 device types, 2 clearances.
Jingzhou Haixin Green Cross Medical Products Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Cap, Surgical, Mask, Surgical and 6 other device types. Its earliest product listing with the FDA dates from 2020.
Registration
| Registered name | JINGZHOU HAIXIN GREEN CROSS MEDICAL PRODUCTS CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3017597597 |
| FEI number | 3017597597 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Location
| City | Jingzhou |
|---|---|
| Province | Hubei |
| Address | Yongxing North Road No.2 |
| Postal code | 434200 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Face Shield | 2020 | 439 |
| Cap, Surgical | Class 1 | Bouffant Cap | 2020 | 178 |
| Cover, Shoe, Operating-Room | Class 1 | Room | 2020 | 176 |
| Gown, Examination | Class 1 | Isolation Gown | 2020 | 109 |
| Gown, Isolation, Surgical | Class 2 | Gown, Isolation, Surgical | 2020 | 21 |
| Mask, Surgical | Class 2 | Earloop Procedure Mask, Surgical Mask, Surgical Mask (Gfm 96, Gfm 91, Gfm 90, Gfm 88, Gfm 81, Gfm 80) | 2020 | 125 |
| Non-Surgical Gown | Class 1 | Cover Gown; Coverall; Impervious Gown; Isolation Gown; Lab Coat; Lab Jacket; Thumbloop Gown; Non-Surgical Isolation Gown | 2020 | 318 |
| Suit, Surgical | Class 1 | Suit Surgical | 2020 | 74 |
Clearances
2 clearances name Jingzhou Haixin Green Cross Medical Products Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K222266 | 2022-09-26 | FXX | Traditional | This company |
| K171535 | 2018-02-15 | FYC | Traditional | This company |
| K123787 | 2013-07-17 | FXX | Traditional | Jingzhou Haixin Green Cross Medical Products Co.,L |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2020 |
|---|---|
| Factory area | 120000 square meters (building area 105000) |
| Main products | Medical masks, Respirators, Hospital apparels, Coverall Type 5/6, Dental disposables |
| Certifications | FDA 510(K), ISO9001:2000, ISO13485:2003, CE, TUV |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Allmed Medical Products Co., Ltd. -Jianli | 4 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.