BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    ACARE TECHNOLOGY CO., LTD.

    Reg #: 3006395447 · FEI: 3006395447 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    45
    Establishment Types
    4
    Classifications
    11

    Registration Details

    Registration Name
    ACARE TECHNOLOGY CO., LTD.
    Registration Number
    3006395447
    FEI Number
    3006395447
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5F-4, No.24, Wuquan 2nd Rd, Xinzhuang District
    City
    New Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K182950

    Owner / Operator

    Firm Name
    ACARE TECHNOLOGY CO., LTD.
    Operator Number
    9096601
    Address
    5F-4, No.24, Wuquan 2nd Rd, Xinzhuang District
    City
    New Taipei City
    State
    TW-NOTA
    Postal Code
    242
    Country
    TW

    US Agent

    Business Name
    Kamm & Associates
    Contact Name
    Daniel Kamm
    Address
    8870 Ravello Ct
    City
    Naples
    State
    FL
    ZIP
    34114
    Country
    US
    Email
    [email protected]
    Phone
    847 3741727

    Products

    Device Name Product Code
    Airway, Oropharyngeal, Anesthesiology CAE
    Regulator, Vacuum KDP
    Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge CCN
    Apparatus, Suction, Ward Use, Portable, Ac-Powered JCX
    Bottle, Collection, Vacuum KDQ
    Oximeter DQA
    Regulator, Pressure, Gas Cylinder CAN
    Non-Surgical Gown OEA
    Strap, Head, Gas Mask BTK
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    Cannula, Nasal, Oxygen CAT

    Proprietary Names

    Acare Spiracle VRV VACTUNE VARIOUS MOD VRA VRA-361 VRF FA-AM FA-AB FA-AT FA-OS FA-OM OXITUNE VARIOUS MODEL FLOWMETERS FA-TA FA-AD FA-OT FA-AS FA-OD FA-TD FA-OB Acare Suction Unit ASU-200 AC-SJ AC-ST9 (Safety Trap) AC-SJ-20 (Suction Bottle) AC-ST AE-O2 OxiSmarter I VSY VSC OXITUNE VARIOUS MODEL REGULATORS VST VSW VST-H01 Isolation gown Headgear Model RAG-100 Headgear Model RAG-200 VAC-300 VAC-100 VAC-200 Acare Technology Co., Ltd AH-M1 Oxi-Q AE-M1 AH-MX

    Establishment Types

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