BEUDAMED
    FDA Registration Active 🇨🇳 China

    Changsha Airdoc Health Technology Co., Ltd.

    Reg #: 3023810198 · FEI: 3023810198 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    Changsha Airdoc Health Technology Co., Ltd.
    Registration Number
    3023810198
    FEI Number
    3023810198
    Status
    Active
    Expiry Year
    2026
    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
    Xiaoli Cao

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Camera, Ophthalmic, General-Use PJZ
    Digital Therapy Device For Convergence Insufficiency SBN

    Proprietary Names

    fundus camera AI-FD16M / fundus cameraAI-FD16M YT-VT2024

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)