FDA Registration
Active
🇨🇳 China
FOREFRONT (XIAMEN) MEDICAL DEVICES CO., LTD.
Reg #: 3007695715
·
FEI: 3007695715
·
Expires 2026
Products
8
Proprietary Names
5
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- FOREFRONT (XIAMEN) MEDICAL DEVICES CO., LTD.
- Registration Number
- 3007695715
- FEI Number
- 3007695715
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.28 Haijing East Road & No.61 Haijing South Road, Xiamen Area of China (Fujian)Pilot Free Trade Zone
- City
- Xiamen Fujian
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K143522
Owner / Operator
- Firm Name
- Forefront (Xiamen) Medical Devices Co., Ltd.
- Operator Number
- 10029104
- Address
- No.28 HAIJING EAST ROAD & NO.61 HAIJING SOUTH ROAD, XIAMEN AREA OF CHINA (FUJIAN) PILOT FREE TRADE ZONE
- City
- Xiamen
- State
- Fujian
- Postal Code
- 361026
- Country
- CN
- Correspondent
- Kelly Chen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Retractor, All Types | EIG | Class 1 | Dental | No | 2019-05-22 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2018-01-24 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2018-01-24 |
| Retractor, Vaginal | HDL | Class 1 | Obstetrics/Gynecology | No | 2023-12-26 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2009-04-05 |
| Syringe, Balloon Inflation | MAV | Class 2 | Cardiovascular | No | 2019-12-20 |
| Light, Operating, Dental | EAZ | Class 1 | Dental | No | 2026-03-17 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2019-05-22 |
Proprietary Names
M1 CAPNOGRAPHY MASK
Soviflex self-retaining vaginal retractor
LMA Laryngeal Mask Airway, Unique,Flexible, Fastract, LMA Proseal, LMA Classic
Presto Inflation Device
LED Adapter
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device