FDA Registration
Active
🇨🇳 China
Wireless Bluetooth Hearing Aid DCM-220
Reg #: 3016171795
·
FEI: 3016171795
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- GUANGDONG ENNO MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3016171795
- FEI Number
- 3016171795
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 406, 4th Floor, Workshop G, No. 8 Hua 'an Road, Zhongkai High-Tech Zone,
- City
- Huizhou Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Guangdong ENNO Medical Technology Co., Ltd.
- Operator Number
- 10091567
- Address
- No. 406, 4th Floor, Workshop G, No. 8 Hua 'an Road, Zhongkai High-Tech Zone,
- City
- Huizhou
- State
- Guangdong
- Postal Code
- 516006
- Country
- CN
- Correspondent
- Tammy. Tan
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2024-10-16 |
Proprietary Names
Wireless Bluetooth Hearing Aid DCM-220
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)