Forefront (Xiamen) Medical Devices Co., Ltd.
Registered establishment in Xiamen, Fujian, China. 8 device types.
Forefront (Xiamen) Medical Devices Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Mask, Oxygen, Retractor, Vaginal and 6 other device types. Its earliest product listing with the FDA dates from 2009.
Registration
| Registered name | FOREFRONT (XIAMEN) MEDICAL DEVICES CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007695715 |
| FEI number | 3007695715 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 法福来（厦门）医疗器具有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Xiamen |
|---|---|
| Province | Fujian |
| Address | No.28 Haijing East Road & No.61 Haijing South Road |
| Postal code | 361026 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Retractor, Dental | Class 1 | 2019 | 37 | |
| Airway, Oropharyngeal, Anesthesiology | Class 1 | LMA Laryngeal Mask Airway, Unique,Flexible, Fastract, LMA Proseal, LMA Classic | 2009 | 84 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Class 2 | M1 Capnography Mask | 2018 | 29 |
| Light, Operating, Dental | Class 1 | LED Adapter | 2026 | 16 |
| Mask, Oxygen | Class 1 | M1 Capnography Mask | 2018 | 126 |
| Retractor, All Types | Class 1 | 2019 | 45 | |
| Retractor, Vaginal | Class 1 | Soviflex self-retaining vaginal retractor | 2023 | 8 |
| Syringe, Balloon Inflation | Class 2 | Presto Inflation Device | 2019 | 6 |
Clearances
No clearance names Forefront (Xiamen) Medical Devices Co., Ltd. as applicant. One 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 |
|---|---|---|---|---|
| K143522 | 2015-01-12 | MAV | Traditional | C.R. Bard, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2002 |
|---|---|
| Main products | Medical device contract manufacturing, Drug delivery systems, Laryngeal masks, Diagnostic devices, Infusion therapy devices |
| Certifications | FDA registered, TUV ISO 13485 |
| Export markets | Global |
| OEM and ODM | Offered |
Nearby Manufacturers
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.