FDA Registration
Active
🇨🇳 China
GUANG DONG EDA TECHNOLOGY CO., LTD.
Reg #: 3015084765
·
FEI: 3015084765
·
Expires 2026
Products
6
Proprietary Names
10
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- GUANG DONG EDA TECHNOLOGY CO., LTD.
- Registration Number
- 3015084765
- FEI Number
- 3015084765
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.3, Minolta Road, Shilong Town,
- City
- Dongguan City Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K243244
Owner / Operator
- Firm Name
- Guang Dong EDA Technology Co., Ltd.
- Operator Number
- 10059483
- Address
- No.3, Minolta Road, Shilong Town
- City
- Dongguan City
- State
- Guangdong
- Postal Code
- 523326
- Country
- CN
US Agent
- Business Name
- Registrar corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2022-01-05 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2019-01-29 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2020-04-22 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2020-04-14 |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | Class 2 | Anesthesiology | No | 2025-08-15 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2020-04-22 |
Proprietary Names
High Flow Nasal Cannula
Rescomf Nasal Cannula
Purity o3
RESCOMF
CPAP Hose Tubing
CPAP Tubing
RESCOMF Tubing
CPAP Hose
Tubing
Rescomf Brand Heated Breathing Tube
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device