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Data / Medical devices / China / Hangzhou Stellarmed Medical Technology Co.,ltd

Hangzhou Stellarmed Medical Technology Co.,ltd: FDA-registered device maker in Hangzhou Zhejiang, China, 1 510(k) clearance

Hangzhou Stellarmed Medical Technology Co.,ltd is registered with the FDA (registration 3017911818) in Hangzhou Zhejiang, China. It lists 15 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 17, 2022. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Hangzhou Stellarmed Medical Technology Co.,ltd
FDA registration number
3017911818
Address
Room 212, Floor 2, Building 2, No.9 Taiji Road Yunhe Street, Yuhang District, Hangzhou Zhejiang, China, 311000
Owner or operator
Hangzhou Stellarmed Medical technology Co.,Ltd (10079659)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
First device listed
December 17, 2020
Registered through
2026
Brand names listed
Bedding, Disposable, Medical-Transport Pad, Bite Block, Cleaner,Ultrasonic,Medical Instrument-Endoscopy Kit, Coloshield Procedure Drape, Non-Sterile, Single Use, Device Organizer, Disposable Endoscopy Adapter Set, ESD Specimen Tray,with pins, Gauze, Sponge, Nonresorbale For Extermal-Gauze and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Cleaning Brushes, For EndoscopeMNL1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Repackager or relabeleraccessdata.fda.gov
Bottle, Collection, VacuumKDQ2Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Cleaner, Ultrasonic, Medical InstrumentFLG1Repackager or relabeleraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Endoscope Channel AccessoryODC2Repackager or relabeleraccessdata.fda.gov
Endoscopic Bite BlockMNK1Contract manufactureraccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Repackager or relabeleraccessdata.fda.gov
Lubricant, PatientKMJ1Repackager or relabeleraccessdata.fda.gov
Non-Surgical GownOEA1Repackager or relabeleraccessdata.fda.gov
Table And Attachments, Operating-RoomBWN1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Repackager or relabeleraccessdata.fda.gov
Tubing, NoninvasiveGAZ2Repackager 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
June 17, 2022K220210Disposable Endoscopy Adapter SetODCSubstantially EquivalentYangzhou Fartley Medical Instrument Technology Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated June 17, 2022. 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.