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.
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- 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
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 17, 2022 | K210315 | Single 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 Forceps | GEI | Substantially Equivalent | Modern Medical Equipment Manufacturing, Ltd. | accessdata.fda.gov |
| October 19, 2021 | K211170 | Single Use Irrigation bipolar cable | GEI | Substantially Equivalent | Modern Medical Equipment Manufacturing, Ltd. | accessdata.fda.gov |
| November 30, 2020 | K200372 | Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil | GEI | Substantially Equivalent | Modern Medical Equipment Manufacturing, Ltd. | accessdata.fda.gov |
| June 16, 2020 | K192542 | Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde | GEI | Substantially Equivalent | Modern Medical Equipment Manufacturing, Ltd. | accessdata.fda.gov |
| May 31, 2018 | K170703 | Single Use Arthroscopic Electrode (with Pencil) | HRX | Substantially Equivalent | Modern Medical Equipment Manufacturing Limited | accessdata.fda.gov |
| September 28, 2017 | K163442 | Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) | GEI | Substantially Equivalent | Modern Medical Equipment Manufacturing Limited | accessdata.fda.gov |
| April 21, 2016 | K152059 | Disposable General Electrode | GEI | Substantially Equivalent | Modern Medical Equipment Manufacturing Limited | accessdata.fda.gov |
| November 21, 2014 | K134006 | DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE | GEI | Substantially Equivalent | Modern Medical Equipment Manufacturing Limited | accessdata.fda.gov |
| May 19, 2010 | K093479 | DISPOSABLE SUCTION AND IRRIGATION SYSTEM | FHF | Substantially Equivalent | Modern Medical Equipment Mfg., Ltd. | accessdata.fda.gov |
| September 14, 2007 | K070812 | DISPOSABLE LAPAROSCOPIC INSTRUMENT | GEI | Substantially Equivalent | Modern Medical Equipment Mfg., Ltd. | accessdata.fda.gov |
| May 6, 2005 | K043036 | NON-STICK ELECTRODE | GEI | Substantially Equivalent | Modern Medical Equipment Mfg., Ltd. | accessdata.fda.gov |
| June 15, 2004 | K032327 | MODERN MEDICAL BIPOLAR FORCEPS | GEI | Substantially Equivalent | Modern Medical Equipment Mfg., Ltd. | accessdata.fda.gov |
| May 13, 2004 | K033003 | SUCTION COAGULATOR | GEI | Substantially Equivalent | Modern Medical Equipment Mfg., Ltd. | accessdata.fda.gov |
| February 27, 2003 | K023966 | DISPOSABLE BI-POLAR CABLE | GEI | Substantially Equivalent | Modern Medical Equipment Mfg., Ltd. | accessdata.fda.gov |
| February 10, 1999 | K984276 | DISPOSABLE ELECTROSURGERY GROUNDING PAD | GEI | Substantially Equivalent | E & M Engineering, Inc. | accessdata.fda.gov |
| July 31, 1996 | K952030 | LOOP/SQUARE ELECTRODE | HGI | Substantially Equivalent | E & M Engineering, Inc. | accessdata.fda.gov |
| February 10, 1995 | K945531 | BLADE ELECTRODE | GEI | Substantially Equivalent | E & M Engineering, Inc. | accessdata.fda.gov |
| June 13, 1994 | K936304 | ELECTROSURGICAL PENCIL | GEI | Substantially Equivalent | E & M Engineering, Inc. | accessdata.fda.gov |
| June 6, 1994 | K936075 | REUSABLE, HAND CONTROLLED ESP | GEI | Substantially Equivalent | E & M Engineering, Inc. | accessdata.fda.gov |
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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.