BEUDAMED
    FDA Registration Active 🇨🇳 China

    EN-N06, EN-N07, EN-N08, EN-N09, EN-N10, EN-N11, EN-N12, EN-N13, EN-N14, EN-N15, EN-N16, EN-N17, EN-N18, EN-N19, EN-N20,

    Reg #: 3016171795 · FEI: 3016171795 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    GUANGDONG ENNO MEDICAL TECHNOLOGY CO., LTD.
    Registration Number
    3016171795
    FEI Number
    3016171795
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 406, 4th Floor, Workshop G, No. 8 Hua 'an Road, Zhongkai High-Tech Zone,
    City
    Huizhou Guangdong
    Country
    CN

    Owner / Operator

    Firm Name
    Guangdong ENNO Medical Technology Co., Ltd.
    Operator Number
    10091567
    Address
    No. 406, 4th Floor, Workshop G, No. 8 Hua 'an Road, Zhongkai High-Tech Zone,
    City
    Huizhou
    State
    Guangdong
    Postal Code
    516006
    Country
    CN
    Correspondent
    Tammy. Tan

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Hearing Aid, Air-Conduction, Over The Counter QUF

    Proprietary Names

    EN-N06, EN-N07, EN-N08, EN-N09, EN-N10, EN-N11, EN-N12, EN-N13, EN-N14, EN-N15, EN-N16, EN-N17, EN-N18, EN-N19, EN-N20, EN-A8, EN-F2, EN-F4, EN-H3, EN-H8, TC-T002, TC-T009, TC-T010, TC-T015, DCM-350, EN-N01, EN-N02, EN-N03, EN-N04, EN-N05, EN-A27, EN-D27, EN-A28, EN-D28, EN-A29, EN-D29B, EN-D29B Pro, EN-A30, EN-D30, EN-A31, EN-D31, EN-A32, EN-D32, EN-A33, EN-D20, EN-A21, EN-D21, EN-A22, EN-D22, EN-D22Pro, EN-A23, EN-D23, EN-A24, EN-D24, EN-A25, EN-D25, EN-A26, EN-D26, EN-IA102C, EN-D102, EN-IA102E, EN-A15, EN-D15, EN-A16, EN-D16, EN-A17, EN-D17, EN-A18, EN-D18, EN-A19, EN-D19, EN-A20, EN-T201D OPENFIT, EN-T201H, EN-T201G, EN-T300, EN-T700, EN-T800, EN-T802, EN-T622, EN-T522, EN-T721, EN-T922, EN-T35, EN-N21, EN-N22, EN-N23, EN-N24, EN-N25, EN-N26, EN-N27, EN-N28, EN-N29, EN-N30, EN-N31, EN-N32, EN-N33, EN-N34, EN-N35, EN-N36, EN-N37, EN-N38, EN-N39, EN-N40, EN-D91, EN-D33, EN-A34, EN-D34, EN-A35, EN-D35, EN-A36, EN-D36, EN-A37, EN-D37, EN-A38, EN-D38, EN-A39, EN-D39, EN-A50, LOOKEE® TrueHear™ A58 OTC Hearing Aid (Model: A58), EN-W33, EN-D32Pro LOOKEE® TrueHear™ A55 OTC Hearing Aid (Model: A55), LOOKEE® TrueHear™ A57 OTC Hearing Aid (Model: A57), EN-A59, EN-D59, EN-A60, EN-D60, EN-RIC-312, EN-RIC-Pro, EN-RIC80, EN-RIC10, EN-OA Li, EN-13 Pro, EN-MCIC80, EN-MCIC10, Hearing aid, amplifiers with models EN-T100, EN-T100A, EN-T100B, EN-T100C, EN-T200, EN-T201A, EN- T201B, EN-T201D, EN-D50, EN-A51, EN-D51, EN-A52, EN-D52, EN-A53, EN-D53, EN-A55, EN-D55, EN-A56, EN-D56, EN-A57, EN-D57, EN-A58, EN-D58, EN-I200 Pro, EN-IA001Pro, EN-IA001A Pro, EN-IA001A, EN-IA001B, EN-IA001C, EN-IA002A, EN-IA003A, EN-IA005A, EN-IA006A, N-IA006A Pro, EN-IA007A, EN-IA008A, EN-IA009A, EN-IA010A, EN-IA011A, EN-IA012A, EN-IA013A, EN-IA102A, EN-IA102B, LOOKEE® TrueHear™ A50 OTC Hearing Aid (Model: A50), LOOKEE® TrueHear™ A51 OTC Hearing Aid (Model: A51),

    Establishment Types

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