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Enter Medical Corporation: FDA-registered device maker in Chiayi County Chiayi(County), Taiwan, 2 510(k) clearances

Enter Medical Corporation is registered with the FDA (registration 3003902679) in Chiayi County Chiayi(County), Taiwan. It lists 21 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 3, 2016. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this oneWatch Enter Medical Corporation
FDA registration number
3003902679
Address
No. 66-5, Yao Tzu Chu, Tsai Kung Village Hsin Kang Township, Chiayi County Chiayi(County), Taiwan, 61642
Owner or operator
ENTER MEDICAL CORPORATION (9054547)
Roles
Exporter to the US, Manufacturer
First device listed
January 2, 2003
Registered through
2026
Brand names listed
Airway Adapter, Airway Connector, Catheter Mount, Catheter Mount and Connectors, Disposable Vacuum Tubing, Dive Mask OPTICAL LENS, Double Swivel Elbow Connector, ENTER and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, CatheterKGZ1Exporter to the US, Manufactureraccessdata.fda.gov
Airway, NasopharyngealBTQ1Exporter to the US, Manufactureraccessdata.fda.gov
Bag, ReservoirBTC1Exporter to the US, Manufactureraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Exporter to the US, Manufactureraccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Exporter to the US, Manufactureraccessdata.fda.gov
Clip, Lens, Trial, OphthalmicHPB1Exporter to the US, Manufactureraccessdata.fda.gov
Connector, Airway (Extension)BZA1Exporter to the US, Manufactureraccessdata.fda.gov
Drain, Tee (Water Trap)BYH1Exporter to the US, Manufactureraccessdata.fda.gov
Endoscopic Bite BlockMNK1Exporter to the US, Manufactureraccessdata.fda.gov
Humidifier, Non-Direct Patient Interface (Home-Use)KFZ1Exporter to the US, Manufactureraccessdata.fda.gov
Laryngoscope, RigidCCW1Exporter to the US, Manufactureraccessdata.fda.gov
Mask, Gas, AnestheticBSJ1Exporter to the US, Manufactureraccessdata.fda.gov
Mask, OxygenBYG1Exporter to the US, Manufactureraccessdata.fda.gov
Screw, OralKBW1Exporter to the US, Manufactureraccessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)BZO1Exporter to the US, Manufactureraccessdata.fda.gov
Strap, Head, Gas MaskBTK1Exporter to the US, Manufactureraccessdata.fda.gov
Tube, Aspirating, Flexible, ConnectingBYY2Exporter to the US, Manufactureraccessdata.fda.gov
Tube, LaryngectomyKAC1Exporter to the US, Manufactureraccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Exporter to the US, Manufactureraccessdata.fda.gov
Valve, Non-RebreathingCBP2Exporter to the US, Manufactureraccessdata.fda.gov
Ventilator, Emergency, Manual (Resuscitator)BTM2Exporter to the US, 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
June 3, 2016K152521Seal Rite Non-Rebreathing ValveCBPSubstantially EquivalentThe Lifeguard Store, Inc.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

Compare with other makers

Updated June 3, 2016. 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.