BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    Fingertip Pulse Oximeter, YK-83C

    Reg #: 3024379416 · FEI: 3024379416 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EHEALTH SCIENCE AND TECHNOLOGY(HONG KONG) CO., LTD
    Registration Number
    3024379416
    FEI Number
    3024379416
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    FLAT/RM 04-05 16/F THE BROADWAY NO 54-62 LOCKHART ROAD WANCHAI
    City
    Hongkong
    Country
    HK

    Regulatory Submissions

    510(k) Number
    K161938

    Owner / Operator

    Firm Name
    EHEALTH SCIENCE AND TECHNOLOGY(HONG KONG) CO., LTD
    Operator Number
    10086256
    Address
    FLAT/RM 04-05 16/F THE BROADWAY NO 54-62 LOCKHART ROAD WANCHAI
    City
    Hongkong
    State
    HK-NOTA
    Postal Code
    000000
    Country
    HK

    US Agent

    Business Name
    IRC USA
    Contact Name
    Charles Mack
    Address
    2950 E Lindrick Dr.
    City
    Chandler
    State
    AZ
    ZIP
    85249
    Country
    US
    Email
    [email protected]
    Phone
    931 6254938

    Products

    Device Name Product Code
    Oximeter DQA

    Proprietary Names

    Fingertip Pulse Oximeter, YK-83C MB1

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device