FDA Registration
Active
🇨🇳 China
fundus camera
Reg #: 3023810198
·
FEI: 3023810198
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Changsha Airdoc Health Technology Co., Ltd.
- Registration Number
- 3023810198
- FEI Number
- 3023810198
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- From Girder No. 3 to Girder No. 13 and Room 501-502, 5th Floor, Building B, Industrial Plant, Otto Technology, Second Industrial Park, No. 13, Huanlian Road, Dongfanghong Street, Changsha Hi-tech Development Zone
- City
- Changsha Hunan
- Country
- CN
Owner / Operator
- Firm Name
- Changsha Airdoc Health Technology Co., Ltd.
- Operator Number
- 10085517
- Address
- From Girder No. 3 to Girder No. 13 and Room 501-502, 5th Floor, Building B, Industrial Plant, Otto Technology, Second Industrial Park, No. 13, Huanlian Road, Dongfanghong Street, Changsha Hi-tech Development Zone
- City
- Changsha
- State
- Hunan
- Postal Code
- 410221
- Country
- CN
- Correspondent
- Yaqin He
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 |
|---|---|---|---|---|---|
| Camera, Ophthalmic, General-Use | PJZ | Class 2 | Ophthalmic | No | 2022-06-27 |
Proprietary Names
fundus camera
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device