GFA Production Xiamen Co., Ltd.
Manufacturer and brand owner in Tong An, Xiamen, Fujian, China. 30 device types, 1 product catalogued.
GFA Production Xiamen Co., Ltd. is a repacker / relabeller holding a current FDA establishment registration. The registration covers Forceps, Pad, Eye and 28 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2010.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3008384335 |
| FEI number | 3008384335 |
| DUNS | 421256261 |
| Establishment type | Repacker / relabeller, Manufacturer |
Location
| City | Tong An, Xiamen |
|---|---|
| Province | Fujian |
| Address | #20 HuLi Industrial Park, Mei Xi Dao |
| Postal code | 361100 |
| Country | China |
What It Makes
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| GFA Production | CBP | 1 |
Clearances
No clearance names GFA Production Xiamen Co., Ltd. as applicant. 6 are held by other companies 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 |
|---|---|---|---|---|
| K202903 | 2022-03-24 | FXX | Traditional | Rizhao Sanqi Medical & Health Articles Co., Ltd. |
| K210691 | 2021-07-30 | LZA | Traditional | Jiangsu Cureguard Glove Co., Ltd. |
| K171961 | 2017-11-17 | CBP | Traditional | Xiamen Compower Medical Tech. Co., Ltd. |
| K163518 | 2017-09-19 | FLL | Traditional | Joytech Healthcare Co., Ltd. |
| K102161 | 2010-10-08 | LYZ | Traditional | Shandong Blue Sail Innovation Co Ltd |
| K070076 | 2007-02-22 | LYZ | Traditional | Jiangsu Cureguard Glove Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2010 |
|---|---|
| Main products | first aid kits, medical emergency supplies, healthcare supplements, hand sanitizer |
| Certifications | FDA cGMP, ISO 9001-2015, MDSAP, Medical Device Production License |
| Export markets | 48 countries |
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.