Data / Medical devices / China / Gmdasz Manufacturing Co., Ltd.
Gmdasz Manufacturing Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 2 510(k) clearances
Gmdasz Manufacturing Co., Ltd. is registered with the FDA (registration 3008197884) in Shenzhen Guangdong, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 11, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008197884
- Address
- Room E1308, Xihaimingzhu Building, Taoyuan Road, Nanshan District, Shenzhen Guangdong, China, 518052
- Owner or operator
- GMDASZ Manufacturing Co., Ltd. (10031210)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 4, 2010
- Registered through
- 2026
- Brand names listed
- 10PK-SNAP-LG, 10PK-SNAP-SM, 10PK-SNAP-XL, 20PK-SNAP-LG, 20PK-SNAP-SM, 20PK-SNAP-XL, 2X2-VALUE-WIRED-20PK, 2X2-VALUE-WIRED-40PK and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| August 11, 2016 | K160138 | Adhesive Electrodes | GXY | Substantially Equivalent | Gmdasz Manufacturing Co., Ltd. | accessdata.fda.gov |
| December 18, 2009 | K092546 | GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM | GXY | Substantially Equivalent | Gmdasz Manufacturing Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 11, 2016. 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.