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Data / Medical devices / Taiwan / Asia Connection Co., Ltd.

Asia Connection Co., Ltd.: FDA-registered device maker in New Taipei City, Taiwan, 19 510(k) clearances

Asia Connection Co., Ltd. is registered with the FDA (registration 3006157842) in New Taipei City, Taiwan. It lists 53 device types. The FDA files 19 510(k) clearances under its listings, the newest dated May 11, 2018. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Asia Connection Co., Ltd.
FDA registration number
3006157842
Address
16F-1, No.16, Jian Ba Road Chung Ho District, New Taipei City, Taiwan, 235603
Owner or operator
ASIA CONNECTION CO., LTD. (10022874)
Roles
Contract manufacturer, Exporter to the US, Manufacturer
First device listed
October 17, 2007
Registered through
2026
Brand names listed
AIRWAY, NASOPHARYNGEAL, Air cushion mask, Airways, Anesthesia Breathing Circuit Kit (Adult & Pediatric), Bandage Scissors, Berman airways, Body Strap Kit, CPR Board and more

Devices it lists

DeviceProduct codeClassRoleSource
Airway, NasopharyngealBTQ1Exporter to the USaccessdata.fda.gov
Airway, Oropharyngeal, AnesthesiologyCAE1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Anesthesia Breathing Circuit Kit (Adult & Pediatric)OFP1Exporter to the USaccessdata.fda.gov
Attachment, Breathing, Positive End Expiratory PressureBYE2Exporter to the USaccessdata.fda.gov
Bedding, Disposable, MedicalKME1Exporter to the USaccessdata.fda.gov
Blood Pressure CuffDXQ2Exporter to the USaccessdata.fda.gov
Board, CardiopulmonaryFOA1Exporter to the USaccessdata.fda.gov
Bottle, Collection, VacuumKDQ2Exporter to the USaccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Exporter to the USaccessdata.fda.gov
Catheter And Tip, SuctionJOL2Exporter to the USaccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Exporter to the USaccessdata.fda.gov
Clip, NoseBXJ1Exporter to the US, Manufactureraccessdata.fda.gov
Compressor, Air, PortableBTI2Exporter to the USaccessdata.fda.gov
Continuous Measurement ThermometerFLL2Exporter to the USaccessdata.fda.gov
Device, Fixation, Tracheal TubeCBH1Exporter to the USaccessdata.fda.gov
Device, Inflation, Middle EarMJVUContract manufactureraccessdata.fda.gov
Filter, Bacterial, Breathing-CircuitCAH2Exporter to the USaccessdata.fda.gov
First Aid Kit Without DrugOHO1Exporter to the USaccessdata.fda.gov
Flowmeter, Tube, Thorpe, Back-Pressure CompensatedCAX1Exporter to the USaccessdata.fda.gov
Mask, Gas, AnestheticBSJ1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Mask, OxygenBYG1Exporter to the USaccessdata.fda.gov
Mask, Oxygen, Low Concentration, VenturiBYF1Exporter to the USaccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Exporter to the USaccessdata.fda.gov
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)CAP2Exporter to the USaccessdata.fda.gov
Monitor, Breathing FrequencyBZQ2Contract manufactureraccessdata.fda.gov
Mouthpiece, BreathingBYP1Exporter to the USaccessdata.fda.gov
Nebulizer (Direct Patient Interface)CAF2Exporter to the USaccessdata.fda.gov
Non-Surgical GownOEA1Exporter to the USaccessdata.fda.gov
Orthosis, Truncal/Orthosis, LimbMRI1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Exporter to the USaccessdata.fda.gov
Polymer Patient Examination GloveLZA1Exporter to the USaccessdata.fda.gov
Pump, Breast, Non-PoweredHGY1Manufactureraccessdata.fda.gov
Regulator, Pressure, Gas CylinderCAN1Exporter to the USaccessdata.fda.gov
Respirator, SurgicalMSH2Exporter to the USaccessdata.fda.gov
Scissors, Medical, DisposableJOK1Exporter to the USaccessdata.fda.gov
Splint, Hand, And ComponentsILH1Exporter to the USaccessdata.fda.gov
Splint, TractionHSP1Exporter to the USaccessdata.fda.gov
Stethoscope, ManualLDE1Exporter to the USaccessdata.fda.gov
Strap, Head, Gas MaskBTK1Exporter to the USaccessdata.fda.gov
Stretcher, Hand-CarriedFPP1Exporter to the USaccessdata.fda.gov
Stretcher, Patient RestraintNZD1Exporter to the USaccessdata.fda.gov
Stretcher, WheeledFPO2Exporter to the USaccessdata.fda.gov
Stylet, Tracheal TubeBSR1Exporter to the USaccessdata.fda.gov
Syringe, EntKCP1Exporter to the US, Manufactureraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Exporter to the US, Manufactureraccessdata.fda.gov
Transducer, Gas PressureBXO1Exporter to the USaccessdata.fda.gov
Tube, Aspirating, Flexible, ConnectingBYY2Exporter to the USaccessdata.fda.gov
Tube, Tracheal (W/Wo Connector)BTR2Exporter to the USaccessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)KNT2Exporter to the USaccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Exporter to the USaccessdata.fda.gov
Valve, Non-RebreathingCBP2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Ventilator, Emergency, Manual (Resuscitator)BTM2Exporter to the USaccessdata.fda.gov
Ventilator, Non-Continuous (Respirator)BZD2Exporter to the USaccessdata.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
May 11, 2018K170663Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable ManometerBTMSubstantially EquivalentForemount Enterprise Co., Ltd.accessdata.fda.gov
June 3, 2016K152521Seal Rite Non-Rebreathing ValveCBPSubstantially EquivalentThe Lifeguard Store, Inc.accessdata.fda.gov
December 18, 2014K140228DISPOSABLE TRACHEAL TUBEBTRSubstantially EquivalentSuzhou Weikang Medical Apparatus Co., Ltd.accessdata.fda.gov
November 10, 2009K091272BESMED JET NEBULIZER BOTTLE SETCAFSubstantially EquivalentBesmed Health Business Corpaccessdata.fda.gov
October 28, 2009K092245ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100DXQSubstantially EquivalentHonsun (Nantong) Co., Ltd.accessdata.fda.gov
July 24, 2009K09118570530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTERCAHSubstantially EquivalentHsiner Co., Ltd.accessdata.fda.gov
February 13, 2009K080105ENDOTRACHEAL TUBEBTRSubstantially EquivalentChilecom Medical Devices Co., Ltd.accessdata.fda.gov
August 22, 2008K082009HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDSCAFSubstantially EquivalentHsiner Co., Ltd.accessdata.fda.gov
February 23, 2007K063268CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235BZDSubstantially EquivalentHsiner Co., Ltd.accessdata.fda.gov
March 22, 2006K053466HSINER RESUSCITATORBTMSubstantially EquivalentHsiner Co., Ltd.accessdata.fda.gov
March 18, 2005K042727POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201ACBPSubstantially EquivalentForemount Ent. Co., Ltd.accessdata.fda.gov
March 11, 2005K042556SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,BTMSubstantially EquivalentEnter Medical Corporationaccessdata.fda.gov
February 18, 2005K042683WELL LEAD ENDOTRACHEAL TUBEBTRSubstantially EquivalentWell Lead Medical Instrumentsaccessdata.fda.gov
September 13, 2004K041692INFRARED EAR THERMOMETER, ET-100 SERIESFLLSubstantially EquivalentHangzhou Hua'An Medical & Health Instruments Co.,accessdata.fda.gov
October 7, 2003K031413VIGORMIST COMPRESSOR NEBULIZERBTISubstantially EquivalentVega Technologies, Inc.accessdata.fda.gov
May 2, 2003K030207NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735LZASubstantially EquivalentShanghai Motex Healthcare Co., Ltd.accessdata.fda.gov
April 3, 2003K022112FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020KNTSubstantially EquivalentFortune Medical Instrument Corp.accessdata.fda.gov
July 23, 2002K020474MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95MSHSubstantially EquivalentMakrite Industries, Inc.accessdata.fda.gov
January 12, 2001K003223GEON DIGITAL CLINICAL THERMOMETERFLLSubstantially EquivalentGeon Corp.accessdata.fda.gov

Compare with other makers

Updated May 11, 2018. 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.