Data / Medical devices / China / Guang Dong Eda Technology Co., Ltd.
Guang Dong Eda Technology Co., Ltd.: FDA-registered device maker in Dongguan City Guangdong, China, 1 510(k) clearance
Guang Dong Eda Technology Co., Ltd. is registered with the FDA (registration 3015084765) in Dongguan City Guangdong, China. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 25, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015084765
- Address
- No.3, Minolta Road, Shilong Town, Dongguan City Guangdong, China, 523326
- Owner or operator
- Guang Dong EDA Technology Co., Ltd. (10059483)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- January 29, 2019
- Registered through
- 2027
- Brand names listed
- CPAP Hose, CPAP Hose Tubing, CPAP Tubing, High Flow Nasal Cannula, Purity o3, RESCOMF, RESCOMF Tubing, Rescomf Brand Heated Breathing Tube and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Nasal, Oxygen | CAT | 1 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Contract manufacturer, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| July 25, 2025 | K243244 | Heated Breathing Tube | BZE | Substantially Equivalent | Guangdong Eda Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Tubing And Support, Ventilator (W Harness)
- All makers of Cannula, Nasal, Oxygen
- All makers of Disinfectant, Medical Devices
- All makers of Mask, Oxygen
- All makers of Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- All makers of Tubing, Pressure And Accessories
Updated July 25, 2025. 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.