FDA Registration
Active
🇨🇳 China
Otoscope,MS450-NTE, MS430, MS500, SA39W, SA39A, NTE430, NTE390, SA39E, AE430, NTE100i
Reg #: 3027303024
·
FEI: 3027303024
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- DONGGUAN HEMS ELECTRONIC TECHNOLOGY CO.,LTD.
- Registration Number
- 3027303024
- FEI Number
- 3027303024
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 301, Building 2, No. 3, Jiaoshe Xinxing Third Road, Dongkeng Town
- City
- Dongguan Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- DONGGUAN HEMS ELECTRONIC TECHNOLOGY Co.,Ltd.
- Operator Number
- 10087576
- Address
- Room 301, Building 2, No. 3, Jiaoshe Xinxing Third Road, Dongkeng Town
- City
- Dongguan
- State
- Guangdong
- Postal Code
- 523000
- Country
- CN
- Correspondent
- Weidong Nie
US Agent
- Business Name
- Humiss Inc.
- Contact Name
- James St WU
- Address
- 1942 Broadway St., STE 314C, Boulder, CO, 80302, USA
- City
- Boulder
- State
- CO
- ZIP
- 80302
- Country
- US
- [email protected]
- Phone
- 720 7595888
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2023-06-27 |
Proprietary Names
Otoscope,MS450-NTE, MS430, MS500, SA39W, SA39A, NTE430, NTE390, SA39E, AE430, NTE100i
769379,70676
AKE390,AKS450,AKE390S,AKS400,AKE390i,M28,SA39i
CT01,CT08,CT09
SA200
AKE100i /AE390/SA160
SA200S,SA160-P,SA160-B,SA39W-P,FMC-S1,FMC-N1,FC100,AM500,AM390
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device