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Data / Medical devices / Hong Kong / Modern Medical Equipment Manufacturing, Ltd.

Modern Medical Equipment Manufacturing, Ltd.: FDA-registered device maker in Kwai Chung, N.T., Hong Kong, 19 510(k) clearances

Modern Medical Equipment Manufacturing, Ltd. is registered with the FDA (registration 8040510) in Kwai Chung, N.T., Hong Kong. It lists 26 device types. The FDA files 19 510(k) clearances under its listings, the newest dated March 17, 2022. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

FDA registration number
8040510
FEI number
1000244733
Address
Unit A, 10/F., Mai Wah Industrial Building 1-7 Wah Sing Street, Kwai Chung, N.T., Hong Kong, --
Owner or operator
Modern Medical Equipment Manufacturing Ltd (9005334)
Roles
Contract manufacturer, Contract sterilizer, Exporter to the US, Manufacturer
First device listed
October 17, 1994
Registered through
2026
Brand names listed
3 button fingerswitch handpiece, Arthrex OPES Electrodes, Blade electrode, CHRISTOUDIAS GAUZE DISSECTOR, CHRISTOUDIAS PERITONEUM TWIN TISSUE APPROXIMATOR, Disposable 2.36mm shaft Electrode - Blade, Disposable 2.36mm shaft, Electrode - Ball, Disposable 2.36mm shaft, Electrode - Needle and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Manufactureraccessdata.fda.gov
ArthroscopeHRX2Contract manufacturer, Manufactureraccessdata.fda.gov
Cannula, Manipulator/Injector, UterineLKF2Contract manufactureraccessdata.fda.gov
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDWF2Contract manufactureraccessdata.fda.gov
Catheter, IrrigationGBX1Contract manufactureraccessdata.fda.gov
Ear, Nose, And Throat Stereotaxic InstrumentPGW2Contract manufactureraccessdata.fda.gov
Electrocautery, Gynecologic (And Accessories)HGI2Contract manufacturer, Manufactureraccessdata.fda.gov
Electrode, ElectrosurgicalJOS2Manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Contract manufacturer, Contract sterilizer, Manufactureraccessdata.fda.gov
Illuminator, Non-RemoteFTF2Contract manufactureraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Contract manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Contract manufactureraccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Contract manufactureraccessdata.fda.gov
Laryngoscope, RigidCCW1Manufactureraccessdata.fda.gov
Light, Examination, Medical, Battery PoweredKYT1Manufactureraccessdata.fda.gov
Massager, Vacuum, Radio Frequency Induced HeatPBX2Contract manufactureraccessdata.fda.gov
Pessary, VaginalHHW2Contract manufactureraccessdata.fda.gov
Stabilizer, HeartMWS1Contract manufactureraccessdata.fda.gov
Staple, Removable (Skin)GDT1Manufactureraccessdata.fda.gov
Stapler, SkinQQS1Manufactureraccessdata.fda.gov
Stylet, Tracheal TubeBSR1Contract manufacturer, Contract sterilizeraccessdata.fda.gov
System, Evacuator, FluidFHF2Exporter to the US, Manufactureraccessdata.fda.gov
Tubing, NoninvasiveGAZ2Manufactureraccessdata.fda.gov
Ventilator, Continuous, Non-Life-SupportingMNS2Contract manufactureraccessdata.fda.gov
Ventilator, Non-Continuous (Respirator)BZD2Contract manufactureraccessdata.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
March 17, 2022K210315Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar ForcepsGEISubstantially EquivalentModern Medical Equipment Manufacturing, Ltd.accessdata.fda.gov
October 19, 2021K211170Single Use Irrigation bipolar cableGEISubstantially EquivalentModern Medical Equipment Manufacturing, Ltd.accessdata.fda.gov
November 30, 2020K200372Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencilGEISubstantially EquivalentModern Medical Equipment Manufacturing, Ltd.accessdata.fda.gov
June 16, 2020K192542Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, ElectordeGEISubstantially EquivalentModern Medical Equipment Manufacturing, Ltd.accessdata.fda.gov
May 31, 2018K170703Single Use Arthroscopic Electrode (with Pencil)HRXSubstantially EquivalentModern Medical Equipment Manufacturing Limitedaccessdata.fda.gov
September 28, 2017K163442Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)GEISubstantially EquivalentModern Medical Equipment Manufacturing Limitedaccessdata.fda.gov
April 21, 2016K152059Disposable General ElectrodeGEISubstantially EquivalentModern Medical Equipment Manufacturing Limitedaccessdata.fda.gov
November 21, 2014K134006DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODEGEISubstantially EquivalentModern Medical Equipment Manufacturing Limitedaccessdata.fda.gov
May 19, 2010K093479DISPOSABLE SUCTION AND IRRIGATION SYSTEMFHFSubstantially EquivalentModern Medical Equipment Mfg., Ltd.accessdata.fda.gov
September 14, 2007K070812DISPOSABLE LAPAROSCOPIC INSTRUMENTGEISubstantially EquivalentModern Medical Equipment Mfg., Ltd.accessdata.fda.gov
May 6, 2005K043036NON-STICK ELECTRODEGEISubstantially EquivalentModern Medical Equipment Mfg., Ltd.accessdata.fda.gov
June 15, 2004K032327MODERN MEDICAL BIPOLAR FORCEPSGEISubstantially EquivalentModern Medical Equipment Mfg., Ltd.accessdata.fda.gov
May 13, 2004K033003SUCTION COAGULATORGEISubstantially EquivalentModern Medical Equipment Mfg., Ltd.accessdata.fda.gov
February 27, 2003K023966DISPOSABLE BI-POLAR CABLEGEISubstantially EquivalentModern Medical Equipment Mfg., Ltd.accessdata.fda.gov
February 10, 1999K984276DISPOSABLE ELECTROSURGERY GROUNDING PADGEISubstantially EquivalentE & M Engineering, Inc.accessdata.fda.gov
July 31, 1996K952030LOOP/SQUARE ELECTRODEHGISubstantially EquivalentE & M Engineering, Inc.accessdata.fda.gov
February 10, 1995K945531BLADE ELECTRODEGEISubstantially EquivalentE & M Engineering, Inc.accessdata.fda.gov
June 13, 1994K936304ELECTROSURGICAL PENCILGEISubstantially EquivalentE & M Engineering, Inc.accessdata.fda.gov
June 6, 1994K936075REUSABLE, HAND CONTROLLED ESPGEISubstantially EquivalentE & M Engineering, Inc.accessdata.fda.gov

Compare with other makers

Updated March 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.