BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    Quick Connect SpO2 Clip, Adult

    Reg #: 3019834104 · FEI: 3019834104 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TONTEC INTERNATIONAL LTD.
    Registration Number
    3019834104
    FEI Number
    3019834104
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    UNIT1209-12, TELFORD HOUSE, WANG HOI ROAD
    City
    KOWLOON BAY, KOWLOON
    Country
    HK

    Regulatory Submissions

    510(k) Number
    K090785

    Owner / Operator

    Firm Name
    Tontec Precision Plastics Technology (Shenzhen) Co. Ltd.
    Operator Number
    10054549
    Address
    55 Buxia Road, Liuyue, Henggang
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    0000
    Country
    CN
    Correspondent
    CHARLES NG

    US Agent

    Business Name
    Treg Tool, Inc.
    Contact Name
    Gert Lykke
    Address
    10 Summer Meadow Rd
    City
    Arden
    State
    NC
    ZIP
    28704
    Country
    US
    Email
    [email protected]
    Phone
    714 4691188

    Products

    Device Name Product Code
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI

    Proprietary Names

    Quick Connect SpO2 Clip, Adult Quick Connect SpO2 Starter Kit Quick Connect SpO2 Grip, Adult, 20/box Quick Connect SpO2 Grip, Neo, 20/box Quick Connect SpO2 Clip, Pediatric Quick Connect SpO2 Grip, Ped, 20/box Quick Connect SpO2 Grip, Infant, 20/box

    Establishment Types

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