Data / Medical devices / China / Suzhou Ennova Electronic Technology Co Ltd
Suzhou Ennova Electronic Technology Co Ltd: FDA-registered device maker in Suzhou Jiangsu, China, 1 510(k) clearance
Suzhou Ennova Electronic Technology Co Ltd is registered with the FDA (registration 3000947648) in Suzhou Jiangsu, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 18, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3000947648
- Address
- The 3rd Floor, Building 2#, No. 1875 Zhong Huayuan West Road, Yushan Town, Kunshan District, Suzhou Jiangsu, China, 215300
- Owner or operator
- Suzhou Ennova Electronic Technology Co Ltd (10051270)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- February 24, 2016
- Registered through
- 2026
- Brand names listed
- Electrocardiograph electrode, Self-adhesive Electrode, CNT-PADS-100
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 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 |
|---|---|---|---|---|---|---|
| February 18, 2016 | K152648 | Ennova Self-adhesive Electrode | GXY | Substantially Equivalent | Suzhou Ennova Electronics Technology Co.,Ltd | accessdata.fda.gov |
Compare with other makers
Updated February 18, 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.