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Data / Medical devices / China / Shanghai Lejoy Co., Ltd

Shanghai Lejoy Co., Ltd: FDA-registered device maker in Shanghai, China, 4 510(k) clearances

Shanghai Lejoy Co., Ltd is registered with the FDA (registration 3020468145) in Shanghai, China. It lists 21 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 19, 2018. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Shanghai Lejoy Co., Ltd
FDA registration number
3020468145
Address
757 Guangfu Road Minmetals Building, Shanghai, China, 200070
Owner or operator
Shanghai Lejoy Co., LTD (10088511)
Roles
Exporter to the US
First device listed
August 21, 2023
Registered through
2026
Brand names listed
ACCESSORY, SURGICAL APPAREL, ANTI FOG SOLUTION AND ACCESSORIES, ENDOSCOPY; LAPAROSCOPE, GENERAL & PLASTIC SURGERY, BASIN, EMESIS, CATHETER AND TIP, SUCTION, COMPONENT, TRACTION, NON-INVASIVE, CONTAINER, LIQUID MEDICATION, GRADUATED, Electrosurgical, cutting & coagulation & accessories, HANDLE, SCALPEL and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Exporter to the USaccessdata.fda.gov
Anti Fog Solution And Accessories, EndoscopyOCT2Exporter to the USaccessdata.fda.gov
Basin, EmesisFNY1Exporter to the USaccessdata.fda.gov
Catheter And Tip, SuctionJOL2Exporter to the USaccessdata.fda.gov
Component, Traction, Non-InvasiveKQZ1Exporter to the USaccessdata.fda.gov
Container, Liquid Medication, GraduatedKYW1Exporter to the USaccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Exporter to the USaccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Exporter to the USaccessdata.fda.gov
Handle, ScalpelGDZ1Exporter to the USaccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Exporter to the USaccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Exporter to the USaccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Exporter to the USaccessdata.fda.gov
Light, Surgical, AccessoriesFTA2Exporter to the USaccessdata.fda.gov
Marker, SkinFZZ1Exporter to the USaccessdata.fda.gov
Needle, Suturing, DisposableGAB1Exporter to the USaccessdata.fda.gov
Non-Surgical GownOEA1Exporter to the USaccessdata.fda.gov
Support, Patient PositionCCX1Exporter to the USaccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Exporter to the USaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Exporter to the USaccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Exporter to the USaccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Exporter to the USaccessdata.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
September 19, 2018K182080Scope Antifogging SystemGCJSubstantially EquivalentXodus Medical, Inc.accessdata.fda.gov
November 3, 2010K102372OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DBGEISubstantially EquivalentJiangmen City Xinhui Baisheng Medical Equipment COaccessdata.fda.gov
August 12, 2008K081647ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPSGEISubstantially EquivalentXodus Medical, Inc.accessdata.fda.gov
January 19, 2006K053321LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVERFTASubstantially EquivalentXodus Medical, Inc.accessdata.fda.gov

Compare with other makers

Updated September 19, 2018. 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.