BEUDAMED
    FDA Registration Active 🇨🇳 China

    FUDAKANG INDUSTRIAL CO LTD

    Reg #: 3008167616 · FEI: 3008167616 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    58
    Establishment Types
    1
    Classifications
    3

    Research this establishment in seconds

    The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Registration Details

    Registration Name
    FUDAKANG INDUSTRIAL CO LTD
    Registration Number
    3008167616
    FEI Number
    3008167616
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    501, Building 2, No. 11 Changheng Road,, Changping Town
    City
    Dongguan Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K160308

    Owner / Operator

    Firm Name
    Fudakang Industrial Co Ltd
    Operator Number
    10031413
    Address
    501, Building 2, No. 11 Changheng Road,, Changping Town
    City
    Dongguan
    State
    Guangdong
    Postal Code
    523560
    Country
    CN
    Correspondent
    Bob Yu

    US Agent

    Business Name
    Fudakang Industrial Inc.
    Contact Name
    Jephanie Chen
    Address
    3514 Raina Ridge Ct
    City
    Las Vegas
    State
    NV
    ZIP
    89121
    Country
    US
    Email
    [email protected]
    Phone
    725 7266008

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL
    Clinical Electronic Thermometer SDV
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    Premom: EBT-380 PREX: BT-A31 shecare:BT-A31, YC-K889B easy @home: EBT-380 (TP500), EBT-089, EBT-300 FDK: BT-A31-BT, BT-A41CN-BT Glow: UO-8064 FDK Infrared Thermometer W/BLUETHOTH:: FT-F11-BT TysonBio Infrared Thermometer W/BLUETHOTH:NC100 TysonBio Thermomter with bluetooth without display: TP-100, TP-200, TP-300, TP-400, TP-500 FDK Thermomter with bluetooth without display: BT-A31A-BT Uone(HK)Industrial Co.,Limited: UO-8080,UO-8080E FDK Infrared Thermometer: FT-F11, FT-F21, FT-F31,FT-F41, FT-F41A, FT-F42, FT-F15, FT-F33 AUPO: FT-F21 FDK: FT-F41 REIZEN infrared Thermometer: FT-F31 (381315) Arrotemp: FT-F31 (P-108425) ADVOCATE: FT-F31 (ASPT-01) dr.Madre: FT-F31 (DRM-22) Clinical Electronic Thermometer FDK: BT-A11CN, BT-A21CN, BT-A41CN, BT-A13 Easy@Home Smart Basal Thermometer: EBT-300 Easy@Home Digital Basal Thermometer: EBT-100, EMT-A12 Premom Smart Basal Thermometer: EBT-380 FDK Electronic Blood Pressure Monitor Arm Type : FT-C26Y-V FDK WRIST CUFF BPM W/BLUETHOTH & UART ( NO VOICE): FT-B13W-BT FDK WRIST CUFF BPM: FT-B31Y FDK ARM CUFF BPM W/NO VOICE: FT-C11B, FT-C12B, FT-C03B, FT-C15B, FT-C22Y, FT-C23Y, FT-C24Y, FT-C26Y FDK ARM CUFF BPM W/BLUETHOTH: FT-C11B-BT Blue Jay Arm & Wrist BPM:FT-C06(BJ120108), FT-B12W(BJ120110) FDK ARM CUFF BPM W/VOICE: FT-C03-V, FT-C03B-V, FT-C11B-V, FT-C12B-V, FT-C15Y-V, FT-C22Y-V, FT-C23Y-V, FT-C24Y-V FDK WRIST CUFF BPM W/BLUETHOTH & UART ( VOICE): FT-B13W-V-BT Sunbeam Wrist BPM : FT-B06W-V & FT-B06W AUPO WRIST CUFF BPM:FT-B13W ChoiceMMed Arm&Wrist BPM: FT-C11B(MDBP12), FT-B12W(BP201) FDK ARM CUFF BLOOD PRESSURE MONITOR: FT-C15B FDK Electronic Blood Pressure Monitor Arm Type : FT-C15Y FDK Electronic Blood Pressure Monitor Arm Type : FT-C24Y FDK Electronic Blood Pressure Monitor Wrist Type : FT-B14W FDK ARM CUFF SPEAKING BLOOD PRESSURE MONITOR: FT-C03-V Proactive Blood Pressure Monitor Arm Type : PMDBPA (FT-C21Y) Reizen Digital Thermometer: BT-A31 ADVOCATE Large Display Backlit Digital Thermometer: BT-A31(ADPT-01) shecare:BT-A12A Safety: TH093, TH094 LPOW: BT-A13 easy@Home: EBT-100(BT-A23), EMT-A12(BT-A12B), EMT-021(BT-A21CN) ANKOVO: BT-A21CN dr.Madre: BT-A41CN (DRM-BT41) SPLENDCARE: BT-A12B(SPT-01) Sunbeam: BT-A22 Pro Temp: BT-A21CN Babyplan: BT-A31CN Ckeep: BT-A11CN, BT-A13 Uone: UO-8064 FDK DIGITAL THERMOMETER : BT-A11CN, BT-A21CN, BT-A31CN, BT-A41CN, BT-A13, BT-A51 BENDI-C: BT-A21B, BT-A21C, BT-A21D, BT-A21E, BT-A21F, BT-A21G, BT-A21H, BT-A21I, BT-A21J ChoiceMMed: BT-A11CN(T100) Banner Health Digital Thermometer: BHTRA01 (BT-A11CN) REIZEN: BT-A31

    Establishment Types

    Manufacture Medical Device