Modern Medical Equipment Manufacturing Ltd.
Registered establishment in Heng Li, Dongguan, Guangdong, China. 26 device types, 8 clearances.
Modern Medical Equipment Manufacturing Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Arthroscope, Stapler, Skin and 24 other device types. Its earliest product listing with the FDA dates from 1994.
26device types registered with the FDA
8510(k) clearances
Registration
| Registered name | MODERN MEDICAL EQUIPMENT MANUFACTURING LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 9680721 |
| FEI number | 3001319476 |
| Establishment type | Contract manufacturer, Contract steriliser, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 鴻圖醫療器材製造廠有限公司 |
|---|---|
| Source | Hong Kong company register lookup |
Location
| City | Heng Li, Dongguan |
|---|---|
| Province | Guangdong |
| Address | DONG XING INDUSTRIAL AREA |
| Postal code | 523462 |
| Country | China |
Group
Modern Medical Equipment Manufacturing Ltd. is one of 2 plants registered under Modern Medical Equipment Manufacturing Ltd.
| Plant | City | Device types |
|---|---|---|
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | 26 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Face Mask | 2020 | 439 |
| Arthroscope | Class 2 | 2015 | 21 | |
| Cannula, Manipulator/Injector, Uterine | Class 2 | H/S Catheter Set 5 French, H/S Catheter Set 7 French | 2014 | 5 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Class 2 | 2016 | 3 | |
| Catheter, Irrigation | Class 1 | Saphenous Vein Distention System | 2017 | 24 |
| Ear, Nose, And Throat Stereotaxic Instrument | Class 2 | 2020 | 3 | |
| Electrocautery, Gynecologic (And Accessories) | Class 2 | Loop/Square Electrode, LLETZ LOOP Electrode | 2007 | 6 |
| Electrode, Electrosurgical | Class 2 | 2019 | 2 | |
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | Blade electrode, Micro needle, 3 button fingerswitch handpiece, Disposable 2.36mm shaft, Electrode – Ball, Disposable 2.36mm shaft Electrode – Blade, Disposable 2.36mm shaft, Electrode – Needle and 41 more | 1994 | 65 |
| Illuminator, Non-Remote | Class 2 | Surch Light Sub-Assembly 5″, Surch Light Sub-Assembly 10″ | 2017 | 2 |
| Instrument, Ent Manual Surgical | Class 1 | 2020 | 11 | |
| Instrument, Manual, Surgical, General Use | Class 1 | 2018 | 110 | |
| Laparoscope, General & Plastic Surgery | Class 2 | Christoudias Peritoneum Twin Tissue Approximator | 2015 | 46 |
| Laparoscope, Gynecologic (And Accessories) | Class 2 | Christoudias Gauze Dissector | 2015 | 7 |
| Laryngoscope, Rigid | Class 1 | 2019 | 44 | |
| Light, Examination, Medical, Battery Powered | Class 1 | Medical Examination | 2003 | 53 |
| Massager, Vacuum, Radio Frequency Induced Heat | Class 2 | 2019 | 13 | |
| Pessary, Vaginal | Class 2 | 2009 | 4 | |
| Stabilizer, Heart | Class 1 | HeartNet FD-1015NS, HeartNet FD-1015 | 2016 | 9 |
| Staple, Removable (Skin) | Class 1 | removable skin staples | 2002 | 20 |
| Stapler, Skin | Class 1 | Disposable Skin Stapler | 2022 | 22 |
| Stylet, Tracheal Tube | Class 1 | Surch Lite | 2023 | 34 |
| System, Evacuator, Fluid | Class 2 | Disposable Suction & Irrigation Sys | 2010 | 2 |
| Tubing, Noninvasive | Class 2 | PlumePort | 2022 | 33 |
| Ventilator, Continuous, Non-Life-Supporting | Class 2 | Nasal-AIR Critical Care | 2005 | 6 |
| Ventilator, Non-Continuous (Respirator) | Class 2 | Nasal-AIR Critical Care, Modification TO Nasal Aire | 2004 | 18 |
Clearances
8 clearances name Modern Medical Equipment Manufacturing Ltd. as applicant. 11 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K210315 | 2022-03-17 | GEI | Traditional | This company |
| K211170 | 2021-10-19 | GEI | Traditional | This company |
| K200372 | 2020-11-30 | GEI | Traditional | This company |
| K192542 | 2020-06-16 | GEI | Traditional | This company |
| K170703 | 2018-05-31 | HRX | Traditional | This company |
| K163442 | 2017-09-28 | GEI | Traditional | This company |
| K152059 | 2016-04-21 | GEI | Traditional | This company |
| K134006 | 2014-11-21 | GEI | Traditional | This company |
| K093479 | 2010-05-19 | FHF | Traditional | Modern Medical Equipment Mfg., Ltd. |
| K070812 | 2007-09-14 | GEI | Special | Modern Medical Equipment Mfg., Ltd. |
| K043036 | 2005-05-06 | GEI | Traditional | Modern Medical Equipment Mfg., Ltd. |
| K032327 | 2004-06-15 | GEI | Traditional | Modern Medical Equipment Mfg., Ltd. |
| K033003 | 2004-05-13 | GEI | Traditional | Modern Medical Equipment Mfg., Ltd. |
| K023966 | 2003-02-27 | GEI | Traditional | Modern Medical Equipment Mfg., Ltd. |
| K984276 | 1999-02-10 | GEI | Traditional | E & M Engineering, Inc. |
| K952030 | 1996-07-31 | HGI | Traditional | E & M Engineering, Inc. |
| K945531 | 1995-02-10 | GEI | Traditional | E & M Engineering, Inc. |
| K936304 | 1994-06-13 | GEI | Traditional | E & M Engineering, Inc. |
| K936075 | 1994-06-06 | GEI | Traditional | E & M Engineering, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.