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Data / Medical devices / China / Zhejiang Baite Medical Appliances Co., Ltd.

Zhejiang Baite Medical Appliances Co., Ltd.: FDA-registered device maker in Huzhou City Zhejiang, China, 1 510(k) clearance

Zhejiang Baite Medical Appliances Co., Ltd. is registered with the FDA (registration 3004134948) in Huzhou City Zhejiang, China. It lists 13 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 17, 2010. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this oneWatch Zhejiang Baite Medical Appliances Co., Ltd.
FDA registration number
3004134948
Address
18 Xinlian Street, Xinshi Town, Deqing County, Huzhou City Zhejiang, China, 313201
Owner or operator
ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD. (9058200)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
August 21, 2003
Registered through
2026
Brand names listed
CORRUGATED TUBING, EYE SHIELD, FACE SHIELD, Humidifier, Infiltration Tubing, MULTIPLE (AEROSOL DRAINAGE SYSTEM), MULTIPLE (NASAL OXYGEN CANNULA, OXYGEN CANNULA), NEBULIZER/NEBULIZER KIT/NEBULIZERS and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Manufactureraccessdata.fda.gov
Bag, ReservoirBTC1Contract manufacturer, Manufactureraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Contract manufacturer, Manufactureraccessdata.fda.gov
Catheter, IrrigationGBX1Contract manufacturer, Manufactureraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Contract manufacturer, Manufactureraccessdata.fda.gov
Humidifier, Non-Direct Patient Interface (Home-Use)KFZ1Manufactureraccessdata.fda.gov
Mask, OxygenBYG1Contract manufacturer, Manufactureraccessdata.fda.gov
Mask, Oxygen, Low Concentration, VenturiBYF1Manufactureraccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Manufactureraccessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)CCQ1Contract manufacturer, Manufactureraccessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)BZO1Contract manufacturer, Manufactureraccessdata.fda.gov
Tracheobronchial Suction Catheter KitOFR1Contract manufacturer, Manufactureraccessdata.fda.gov
Vinyl Patient Examination GloveLYZ1Manufacturer, Repackager or relabeleraccessdata.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
August 17, 2010K101565POWDER - FREE PATIENT EXAMINATION GLOVESLYZSubstantially EquivalentZibio Yingjie Medical Products Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated August 17, 2010. 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.