Data / Medical devices / China / Wuhan Greentek Pty Ltd.
Wuhan Greentek Pty Ltd.: FDA-registered device maker in Wuhan Hubei, China, 2 510(k) clearances
Wuhan Greentek Pty Ltd. is registered with the FDA (registration 3010515191) in Wuhan Hubei, China. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 8, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010515191
- Address
- Room 03-2, Floor 3, Building 3, Phase III, International Enterprise Center, Special No.1, Guanggu Avenue East Lake High-tech Development Zone, Wuhan Hubei, China, 430074
- Owner or operator
- Wuhan Greentek Pty Ltd. (10071887)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- April 24, 2020
- Registered through
- 2026
- Brand names listed
- Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP), GT5 conductive & abrasive gel, M-Quick connector cable (Model: AM)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Media, Electroconductive | GYB | 2 | Exporter to the US, Manufacturer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 8, 2021 | K212787 | GT5 conductive & abrasive gel | GYB | Substantially Equivalent | Wuhan Greentek Pty , Ltd. | accessdata.fda.gov |
| April 21, 2020 | K200162 | Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) | GXY | Substantially Equivalent | Wuhan Greentek Pty , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Cutaneous
- All makers of Media, Electroconductive
- All makers of Cable, Electrode
Updated November 8, 2021. 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.