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Data / Medical devices / China / Ningbo Huakun Medical Equipment Co.,ltd

Ningbo Huakun Medical Equipment Co.,ltd: FDA-registered device maker in Cixi Zhejiang, China, 1 510(k) clearance

Ningbo Huakun Medical Equipment Co.,ltd is registered with the FDA (registration 3009747810) in Cixi Zhejiang, China. It lists 19 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 8, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3009747810
Address
NO.208 Binjiang Road, Cixi High-tech Industrial Development Zone, Cixi Zhejiang, China, 315301
Owner or operator
Ningbo Huakun Medical Equipment Co.,ltd (10041496)
Roles
Contract sterilizer, Manufacturer
First device listed
July 31, 2012
Registered through
2026
Brand names listed
AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY, Anesthesia Breathing Circuit Kit (Adult & Pediatric), BAG, RESERVOIR, Bottle, Collection, Vacuum, CATHETERS, SUCTION, TRACHEOBRONCHIAL, CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE), Catheter trimmer, DEVICE, FIXATION, TRACHEAL TUBE and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, CatheterKGZ1Manufactureraccessdata.fda.gov
Airway, Oropharyngeal, AnesthesiologyCAE1Manufactureraccessdata.fda.gov
Anesthesia Breathing Circuit Kit (Adult & Pediatric)OFP1Manufactureraccessdata.fda.gov
Bag, ReservoirBTC1Manufactureraccessdata.fda.gov
Bottle, Collection, VacuumKDQ2Manufactureraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Manufactureraccessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)BYD1Manufactureraccessdata.fda.gov
Cutter, SurgicalFZT1Manufactureraccessdata.fda.gov
Device, Fixation, Tracheal TubeCBH1Manufactureraccessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-UrologyFBK2Contract sterilizeraccessdata.fda.gov
Filter, Bacterial, Breathing-CircuitCAH2Manufactureraccessdata.fda.gov
Hemostatic Metal Clip For The Gi TractPKL2Contract sterilizeraccessdata.fda.gov
Instrument, Ultrasonic SurgicalLFLUContract sterilizeraccessdata.fda.gov
Laryngoscope, RigidCCW1Manufactureraccessdata.fda.gov
Mask, Gas, AnestheticBSJ1Manufactureraccessdata.fda.gov
Mask, OxygenBYG1Manufactureraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Manufactureraccessdata.fda.gov
Support, Breathing TubeJAY1Manufactureraccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Manufactureraccessdata.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
February 8, 2023K221472Filter and HME/FilterCAHSubstantially EquivalentNingbo Huakun Medical Equipment Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated February 8, 2023. 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.