BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Carilex Medical, Inc.

    Reg #: 9710603 · FEI: 3003513125 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    67
    Establishment Types
    2
    Classifications
    9

    Registration Details

    Registration Name
    Carilex Medical, Inc.
    Registration Number
    9710603
    FEI Number
    3003513125
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 77, Keji 1st Rd.
    City
    Guishan District Taoyuan
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K172725

    Owner / Operator

    Firm Name
    Carilex Medical, Inc.
    Operator Number
    9048086
    Address
    No. 77, Keji 1st Rd.
    City
    Guishan Townshiip
    State
    Taoyuan
    Postal Code
    333
    Country
    TW

    US Agent

    Business Name
    mdi Consultants Inc
    Contact Name
    Alan Schwartz
    Address
    55 Northern Blvd Ste 200
    City
    Great Neck
    State
    NY
    ZIP
    11021
    Country
    US
    Email
    [email protected]
    Phone
    516 4829001

    Products

    Device Name Product Code
    Bottle, Collection, Vacuum KDQ
    Mattress, Flotation Therapy, Non-Powered IKY
    Negative Pressure Wound Therapy Powered Suction Pump OMP
    Device, Transfer, Patient, Manual FMR
    Bed, Flotation Therapy, Powered IOQ
    Lift, Patient, Ac-Powered FNG
    Mattress, Air Flotation, Alternating Pressure FNM
    Cushion, Flotation KIC
    Device, Patient Transfer, Powered FRZ

    Proprietary Names

    S1001-6130 Canister for VT 100 - 500ml lock NX S1004-6010 Canister for VT One 150ml S1001-6100 Canister for VT 100 - 300ml luer lock S1001-6110 Canister for VT 100 - 500ml luer lock S1001-6140 Canister for VT 100 - 1000ml lock NX S1004-6030 Canister for VT One - 150ml Luer Lock S1001-6060 Canister for VT 100 300ml lock S1001-6040 Canister for VT 100 1000ml lock S1001-6020 Canister for VT 100 500ml lock S1001-6120 Canister for VT 100 - 300ml lock NX S1001-2150 VT Drape and Port Set Kit L Lock S1001-2200 VT Dressing Kit TS S Carilex S1001-2040 VT Dressing Kit S Carilex S1001-2220 VT Dressing Kit TS L Carilex S1001-8300 VT Drape 2pcs pack S1001-8200 VT 100 Y Connector S1001-2180 VT Dressing Kit NX L Carilex S1001-2130 VT Drape and Port Set Kit S Lock S1001-8160 VT Port Set Kit S1001-2160 VT Dressing Kit NX S Carilex S1001-8190 VT Instill Port Set Kit S1001-2050 VT Dressing Kit M Carilex S1001-8180 VT Dressing Universal Adaptor S1001-2170 VT Dressing Kit NX M Carilex S1001-2120 VT Dressing Kit XL Carilex S1001-8220 VT NX Port Set Kit S1001-2190 VT Dressing Kit NX XL Carilex S1001-2060 VT Dressing Kit L Carilex S1001-2100 VT Spiral Dressing Kit Black Lock S1001-2210 VT Dressing Kit TS M Carilex S1001-2140 VT Drape and Port Set Kit M Lock S1002-3062 VT 200-i NX PU Global Carilex S1002-3022 VT 200-i PU Global Carilex S1002-3052 VT 200 NX PU Global Carilex S1002-0062 VT 200-i NX SYS Global Carilex S1002-0022 VT 200-i SYS Global Carilex S1002-0052 VT 200 NX SYS Global Carilex S1001-0033 VT 100 SYS Global Lock Carilex S1001-3033 VT 100 PU Global Lock Carilex S1002-3012 VT 200 PU Global Carilex S1002-0012 VT 200 SYS Global Carilex TheraFlo 9 Mattress TheraFlo 7 Mattress TheraFlo AVA LAL TheraFlo AP 9 Airrapy Blower DualFlex ePhysio10-12 AVA Cure S2304-3022 CozinyPlus P.U. Global Carilex Centrius Entrina FIT Mattress Envelop S2302-2010 Coziny 100 M-set 41 x 70cm DTX Carilex LUX Mattress AVA Activity Analytics Entrix NX S2302-2020 Coziny 200 M-set 49 x 75cm DTX Carilex Dual S2302-2030 Coziny 300 M-set 70 x 140cm DTX Carilex S1004-3012 VT One PU Global Carilex S1004-3022 VT One 60 Days PU Global Carilex S1004-0012 VT One SYS Global Carilex S1004-0022 VT One 60 Days SYS Global Carilex Cari Chair

    Establishment Types

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