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Data / Medical devices / China / GaleMed (Xiamen) Co., Ltd.

GaleMed (Xiamen) Co., Ltd.: FDA-registered device maker in XIAMEN Fujian, China, 8 510(k) clearances

GaleMed (Xiamen) Co., Ltd. is registered with the FDA (registration 3006783791) in XIAMEN Fujian, China. It lists 34 device types. The FDA files 8 510(k) clearances under its listings, the newest dated April 14, 2014. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch GaleMed (Xiamen) Co., Ltd.
FDA registration number
3006783791
Address
Xiamen Area of China (Fujian) Pilot Free Trade Zone, 39, Section 3, Haijing East Road 361026 Fujian Province, China, XIAMEN Fujian, China, 361026
Owner or operator
GaleMed Corporation (8043316)
Roles
Contract manufacturer, Exporter to the US, Manufacturer
First device listed
September 15, 2004
Registered through
2026
Brand names listed
1" Response Manual Resuscitator, Adult, 1" Response Pediatric Manual Resuscitator, Child large, 1ST RESPONSE INFANT MANUAL RESUSCITATOR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, 2L NON-LATEX BREATHING BAG, 4.3mm Luer Cap Thread Type Color: Blue, ADU Connector, ADULT NASAL CANNULA W/O TUBING and more

Devices it lists

DeviceProduct codeClassRoleSource
Airway, Oropharyngeal, AnesthesiologyCAE1Contract manufacturer, Manufactureraccessdata.fda.gov
Attachment, Breathing, Positive End Expiratory PressureBYE2Contract manufacturer, Manufactureraccessdata.fda.gov
Bag, ReservoirBTC1Contract manufacturer, Manufactureraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Contract manufacturer, Manufactureraccessdata.fda.gov
Cardiopulmonary Resuscitation Aid KitOEV2Manufactureraccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Contract manufacturer, Manufactureraccessdata.fda.gov
Clip, NoseBXJ1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)BYD1Manufactureraccessdata.fda.gov
Connector, Airway (Extension)BZA1Contract manufacturer, Manufactureraccessdata.fda.gov
Continuous, Minimal Ventilatory Support, Facility Use VentilatorMNT2Contract manufactureraccessdata.fda.gov
Drain, Tee (Water Trap)BYH1Contract manufacturer, Manufactureraccessdata.fda.gov
Exerciser, Non-MeasuringION1Contract manufactureraccessdata.fda.gov
Exerciser, Non-Measuring For Stroke RehabilitationPKS1Contract manufactureraccessdata.fda.gov
Filter, Bacterial, Breathing-CircuitCAH2Contract manufactureraccessdata.fda.gov
Gas, Collecting VesselKGK1Manufactureraccessdata.fda.gov
Humidifier, Respiratory Gas, (Direct Patient Interface)BTT2Contract manufactureraccessdata.fda.gov
Mask, Gas, AnestheticBSJ1Contract manufacturer, Manufactureraccessdata.fda.gov
Mask, OxygenBYG1Contract manufacturer, Manufactureraccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Contract manufacturer, Manufactureraccessdata.fda.gov
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)CAP2Manufactureraccessdata.fda.gov
Mouthpiece, BreathingBYP1Contract manufacturer, Manufactureraccessdata.fda.gov
Nebulizer (Direct Patient Interface)CAF2Manufactureraccessdata.fda.gov
Regulator, Pressure, Gas CylinderCAN1Contract manufacturer, Manufactureraccessdata.fda.gov
Resuscitator, Manual, Non Self-InflatingNHK2Manufactureraccessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)BZO1Contract manufacturer, Manufactureraccessdata.fda.gov
Spirometer, Monitoring (W/Wo Alarm)BZK2Contract manufactureraccessdata.fda.gov
Strap, Head, Gas MaskBTK1Manufactureraccessdata.fda.gov
Transducer, Gas PressureBXO1Manufactureraccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Contract manufacturer, Manufactureraccessdata.fda.gov
Valve, Non-RebreathingCBP2Contract manufactureraccessdata.fda.gov
Ventilator, Continuous, Facility UseCBK2Contract manufactureraccessdata.fda.gov
Ventilator, Emergency, Manual (Resuscitator)BTM2Contract manufacturer, Manufactureraccessdata.fda.gov
Ventilator, Emergency, Powered (Resuscitator)BTL2Contract manufactureraccessdata.fda.gov
Ventilator, Non-Continuous (Respirator)BZD2Contract 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
April 14, 2014K133957DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USEBYESubstantially EquivalentGalemed Corp.accessdata.fda.gov
November 18, 2010K102377VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0CAPSubstantially EquivalentA Plus Medicalaccessdata.fda.gov
November 23, 2009K092687VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETERNHKSubstantially EquivalentA Plus Medicalaccessdata.fda.gov
October 15, 2008K082092DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVEBTMSubstantially EquivalentGalemed Corp.accessdata.fda.gov
November 16, 2007K072755GALEMED CPAP MASKBZDSubstantially EquivalentGalemed Corp.accessdata.fda.gov
October 25, 2002K021742GALEMED NEB-EASY NEBULIZERCAFSubstantially EquivalentGalemed Corp.accessdata.fda.gov
June 7, 1995K951043AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASKBSJSubstantially EquivalentPromedic, Inc.accessdata.fda.gov
March 30, 1990K895589MANUAL RESUSCITATORBTMSubstantially EquivalentHudson Oxygen Therapy Sales Co.accessdata.fda.gov

Compare with other makers

Updated April 14, 2014. 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.