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Data / Medical devices / China / Shenzhen Hugemed Medical Technical Development Co., Ltd

Shenzhen Hugemed Medical Technical Development Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 10 510(k) clearances

Shenzhen Hugemed Medical Technical Development Co., Ltd is registered with the FDA (registration 3012797688) in Shenzhen Guangdong, China. It lists 24 device types. The FDA files 10 510(k) clearances under its listings, the newest dated May 14, 2026. Registered through 2027. FDA data exported November 3, 2026.

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Get makers like this oneWatch Shenzhen Hugemed Medical Technical Development Co., Ltd
FDA registration number
3012797688
Address
1801, Luohu New Materials Building, No. 6, Qingyuan Road, Qingshuihe Community, Qingshuihe Street, Luohu District, Shenzhen Guangdong, China, 518024
Owner or operator
Shenzhen HugeMed Medical Technical Development Co., Ltd (10052108)
Roles
Exporter to the US, Manufacturer
First device listed
June 15, 2016
Registered through
2027
Brand names listed
BS-3P-0612/11, BS-3P-0712/08, BS-3P-0712/11,, Grapix™ Disposable Urologic Grasping Forceps FG-VCE-2007-F1, I-CB-72540R, I-CB-72307R, I-CB-72507R, I-CB-72521R, I-LW-2090018/3A, I-LW-2090024/3A,, I-DLP-03AC-40AT-0100, I-DLP-03AC-40AT-0100, I-DLP-03BC-40AT-0100,, I-DLP-03AD-40AM-0100, I-DLP-03AD-40AM-0100, I-DLP-03BD-40AM-0100,, I-DLP-03AK-40AS-0100, I-DLP-03AK-40AS-0100, I-DLP-03BK-40AS-0100,, I-DLP-03BB-40AS-0100, I-DLP-03BB-40AS-0100, I-DLP-05AB-40AS-0100,, I-DLP-03BC-40AT-0100, I-DLP-05AC-40AT-0100, I-DLP-05AC-40AT-0100, and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Photographic, For Endoscope (Exclude Light Sources)FEM1Manufactureraccessdata.fda.gov
Bottle, Collection, VacuumKDQ2Manufactureraccessdata.fda.gov
Bronchoscope (Flexible Or Rigid)EOQ2Manufactureraccessdata.fda.gov
Cable, ElectrodeIKD2Exporter to the USaccessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)DSA2Exporter to the USaccessdata.fda.gov
Camera, Surgical And AccessoriesKQM1Manufactureraccessdata.fda.gov
Choledochoscope And Accessories, Flexible/RigidFBN2Manufactureraccessdata.fda.gov
Container, Specimen, SterileFMH1Manufactureraccessdata.fda.gov
Cystoscope And Accessories, Flexible/RigidFAJ2Manufactureraccessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, MetalFFL2Manufactureraccessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-UrologyFED2Manufactureraccessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-Powered, ExemptPTS2Manufactureraccessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-UrologyOCY2Manufactureraccessdata.fda.gov
Endoscopic Video Imaging System/Component, Gastroenterology-UrologyFET2Manufactureraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Manufactureraccessdata.fda.gov
Laryngoscope, Non-RigidCAL1Manufactureraccessdata.fda.gov
Laryngoscope, RigidCCW1Manufactureraccessdata.fda.gov
Lavage, JetFQH2Manufactureraccessdata.fda.gov
Led Light SourceNTN2Manufactureraccessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)EOB2Manufactureraccessdata.fda.gov
OximeterDQA2Exporter to the USaccessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)BTA2Manufactureraccessdata.fda.gov
Stand, InfusionFOX1Manufactureraccessdata.fda.gov
Ureteroscope And Accessories, Flexible/RigidFGB2Manufactureraccessdata.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 14, 2026K260892Suction Pump (SU-90)BTASubstantially EquivalentShenzhen HugeMed Medical Technical Development Co., Ltd.accessdata.fda.gov
July 8, 2025K250695Single-use Ureteral Access SheathFEDSubstantially EquivalentShenzhen HugeMed Medical Technical Development Co., Ltd.accessdata.fda.gov
January 21, 2025K241444Biliary Pancreaticobiliary Scope SystemFBNSubstantially EquivalentShenzhen HugeMed Medical Technical Development Co., Ltd.accessdata.fda.gov
May 10, 2024K240374Ureterorenoscope SystemFGBSubstantially EquivalentShenzhen HugeMed Medical Technical Development Co., Ltd.accessdata.fda.gov
April 26, 2024K232435Rhinolaryngoscope systemEOBSubstantially EquivalentShenzhen HugeMed Medical Technical Development Co., Ltd.accessdata.fda.gov
March 6, 2024K231497Choledochoscope SystemFBNSubstantially EquivalentShenzhen HugeMed Medical Technical Development Co., Ltd.accessdata.fda.gov
November 13, 2023K231118Cystoscope SystemFAJSubstantially EquivalentShenzhen HugeMed Medical Technical Development Co., Ltd.accessdata.fda.gov
April 11, 2023K222910Bronchoscope SystemEOQSubstantially EquivalentShenzhen HugeMed Medical Technical Development Co., Ltd.accessdata.fda.gov
April 24, 2017K170536ECG Disposable Lead WireDSASubstantially EquivalentAPK Technology Co., Ltd.accessdata.fda.gov
April 3, 2009K082846APK SPO2 PULSE OXIMETER SENSORDQASubstantially EquivalentAPK Technology Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated May 14, 2026. 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.