Zumax Medical Co., Ltd.
Manufacturer and brand owner in Suzhou, Jiangsu, China. 19 device types, 12 products catalogued, 1 clearance.
Zumax Medical Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Otoscope, Speculum, Ent and 17 other device types. 12 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2006.
Registration
| Registered name | ZUMAX MEDICAL CO, LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006252153 |
| FEI number | 3006252153 |
| DUNS | 421348837 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer |
Chinese Registration
| Chinese legal name | 苏州速迈医学科技股份有限公司 |
|---|---|
| Unified social credit code | 91320505771515993L |
| Source | NMPA UDI database |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | 5 ZHIYING STREET |
| Postal code | 215129 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Biomicroscope, Slit-Lamp, Ac-Powered, Exempt | Class 2 | SL200 Handheld slit lamp, SL260 slit lamp | 2019 | 12 |
| Blood Pressure Cuff | Class 2 | 485-0630, 485-0081, SM630, SM620, 485-0080, 485-0625 | 2016 | 50 |
| Colposcope (And Colpomicroscope), Exempt | Class 2 | CLS3080 Colposcope | 2024 | 4 |
| Device, Medical Examination, Ac Powered | Class 1 | 2017 | 18 | |
| Instrument, Hand, Calculus Removal | Class 1 | Broken Instrument Removal Kit | 2016 | 13 |
| Instrument, Microsurgical | Class 1 | Micro Needle Holder Forceps, Micro Tweezers, Micro Scissors | 2025 | 6 |
| Light, Examination, Medical, Battery Powered | Class 1 | 2017 | 53 | |
| Light, Surgical Headlight | Class 1 | HL8300 Headlight, HL8000 Headlight, HL8200 Headlight, HL8260 Headlight, Headlights, HL8350 Headlight | 2006 | 7 |
| Loupe, Binocular, Low Power | Class 1 | Various Models Binocular Loupes, SLF Binocular Loupes, SLT Binocular Loupes, SLH Binocular Loupes, SLE Binocular Loupes, DFT Binocular Loupes and 5 more | 2006 | 13 |
| Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | Class 1 | OMS2650 ophthalmic microscope, OMS2680 ophthalmic microscope | 2025 | 12 |
| Microscope, Surgical, General & Plastic Surgery | Class 1 | OMS6000 surgical microscope, OMS2680 surgical microscope, OMS2300 surgical microscope, OMS2350 surgical microscope, OMS2650 surgical microscope, OMS1950 surgical microscope and 15 more | 2006 | 11 |
| Ophthalmoscope, Ac-Powered | Class 2 | DM6FP Ophthalmoscope, DM6GP Ophthalmoscope, DM6G Ophthalmoscope, DM6F Ophthalmoscope, DW1050, DW2010 and 5 more | 2016 | 7 |
| Ophthalmoscope, Battery-Powered | Class 2 | 485 0010, 489 0010, 467E7860, DM6BE, DW3000, 490-0015 and 22 more | 2016 | 11 |
| Otoscope | Class 1 | OT8DS, OT8V, OT8G, OT8H, Otoscope, OT8 series otoscopes and 6 more | 2006 | 43 |
| Retinoscope, Ac-Powered | Class 2 | SR24F Streak Retinoscope, SR24G Streak Retinoscope | 2017 | 2 |
| Retinoscope, Battery-Powered | Class 1 | DW3050, SR24A Streak Retinoscopes, SR24B Streak Retinoscopes, SR24 Streak Retinoscopes | 2006 | 8 |
| Speculum, Ent | Class 1 | 2016 | 9 | |
| Transilluminator, Battery-Powered | Class 1 | 472E0010, GL50 Series Illuminator, GL60 Series Illuminator | 2019 | 2 |
| Unit, Suction Operatory | Class 1 | DSD-01 Dental Suction Unit | 2024 | 23 |
Own-Brand Listings
Clearances
1 clearance names Zumax Medical Co., Ltd. as applicant. 1 is held by another company 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 |
|---|---|---|---|---|
| K252464 | 2026-04-28 | NBL | Traditional | This company |
| K141392 | 2014-07-02 | DXQ | Traditional | Suzhou JJ Meter Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2005 |
|---|---|
| Employees | 300+ |
| Main products | Dental surgical microscopes, Ophthalmic microscopes, ENT surgical microscopes, Neurosurgery microscopes |
| Certifications | ISO, FDA, CE-ITE, IPMS, Multiple patents |
| Export markets | 120+ countries and regions |
Nearby Manufacturers
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.