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Data / Medical devices / China / Forefront (xiamen) Medical Devices Co., Ltd.

Forefront (xiamen) Medical Devices Co., Ltd.: FDA-registered device maker in Xiamen Fujian, China, 1 510(k) clearance

Forefront (xiamen) Medical Devices Co., Ltd. is registered with the FDA (registration 3007695715) in Xiamen Fujian, China. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 12, 2015. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3007695715
Address
No.28 Haijing East Road & No.61 Haijing South Road Xiamen Area of China (Fujian)Pilot Free Trade Zone, Xiamen Fujian, China, 361026
Owner or operator
Forefront (Xiamen) Medical Devices Co., Ltd. (10029104)
Roles
Contract manufacturer, Manufacturer
First device listed
April 5, 2009
Registered through
2026
Brand names listed
LED Adapter, LMA Laryngeal Mask Airway, Unique,Flexible, Fastract, LMA Proseal, LMA Classic, M1 CAPNOGRAPHY MASK, Presto Inflation Device, Soviflex self-retaining vaginal retractor

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Retractor, DentalEIF1Contract manufactureraccessdata.fda.gov
Airway, Oropharyngeal, AnesthesiologyCAE1Contract manufactureraccessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Contract manufactureraccessdata.fda.gov
Light, Operating, DentalEAZ1Contract manufactureraccessdata.fda.gov
Mask, OxygenBYG1Contract manufactureraccessdata.fda.gov
Retractor, All TypesEIG1Contract manufactureraccessdata.fda.gov
Retractor, VaginalHDL1Contract manufactureraccessdata.fda.gov
Syringe, Balloon InflationMAV2Contract manufacturer, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 12, 2015K143522Presto Inflation DeviceMAVSubstantially EquivalentC.R. Bard, Inc.accessdata.fda.gov

Compare with other makers

Updated January 12, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.