BEUDAMED
    FDA Registration Active 🇨🇳 China

    Apex Medical (Kunshan) Corp.

    Reg #: 3006339858 · FEI: 3006339858 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    34
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    Apex Medical (Kunshan) Corp.
    Registration Number
    3006339858
    FEI Number
    3006339858
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.1368, Zi Zhu Rd., Kunshan Kai Fa Hi-Tech,
    City
    Kunshan City Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K251466

    Owner / Operator

    Firm Name
    Wellell Inc.
    Operator Number
    9001426
    Address
    No. 9, MIN SHENG ST., TU-CHENG,
    City
    NEW TAIPEI CITY
    State
    TW-TPE
    Postal Code
    236044
    Country
    TW
    Correspondent
    Chieh - Yang

    US Agent

    Business Name
    WELLELL AMERICA CORP.
    Contact Name
    Elsa Chu
    Address
    927 Mariner Street, Brea, CA 92821, USA
    City
    Brea
    State
    CA
    ZIP
    92821
    Country
    US
    Email
    [email protected]
    Phone
    714 6713818

    Products

    Device Name Product Code
    Mattress, Air Flotation, Alternating Pressure FNM
    Sleeve, Limb, Compressible JOW
    Cushion, Flotation KIC
    Nebulizer (Direct Patient Interface) CAF

    Proprietary Names

    Sedens 500 ACS Series Pump and Mattress SERENE Series Pump and Mattress Serene Bariatric Optima Auto Optima Prone Optima Turn PRO-CARE Series Pump and Mattress DOMUS 3 Pump and Mattress DOMUS Auto Pump and Mattress Sedens 400 DOMUS 2S Pump and Mattress Procare Elite Procare Auto Link G3 Domus ECO Domus 1 G2 Procare Auto G2 DOMUS 1 Pump and Mattress Domus Auto G2 Domus Bariatric G2 DOMUS 4 Pump and Mattress Domus 3D Serene Elite Serene Air Domus 4 G2 Pump Procare Bariatric G2 Procare Auto G3 Domus 2 G2 Sedens 500 SE Crossover Nio VenAir, Sequential Compression System Procare Auto G3 Seat cushion Mini Star Minicare

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device