BEUDAMED
    FDA Registration Active 🇨🇳 China

    SPY Cystoscope/Hysteroscope, Autoclavable, KS-Series, 4 mm x 30°, 30 cm

    Reg #: 3011459664 · FEI: 3011459664 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    QINGDAO O-MEC MEDICAL TECHNOLOGY CO., LTD.
    Registration Number
    3011459664
    FEI Number
    3011459664
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.100 Keyuanweisi Rd.
    City
    Qingdao Shandong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K233635

    Owner / Operator

    Firm Name
    Qingdao O-Mec Medical Technology Co., Ltd.
    Operator Number
    10048000
    Address
    No.100 Keyuanweisi Rd.
    City
    Qingdao
    State
    Shandong
    Postal Code
    266100
    Country
    CN
    Correspondent
    Linda Cong

    US Agent

    Business Name
    OMEC Medical NV Inc.
    Contact Name
    Claire Nippress
    Address
    5690 Riggins Ct
    City
    Reno
    State
    NV
    ZIP
    89502
    Country
    US
    Email
    [email protected]
    Phone
    775 3606339

    Products

    Device Name Product Code
    Endoscope, Accessories, Narrow Band Spectrum NWB
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Hysteroscope (And Accessories) HIH

    Proprietary Names

    SPY Cystoscope/Hysteroscope, Autoclavable, KS-Series, 4 mm x 30°, 30 cm SPY Cystoscope/Hysteroscope, Autoclavable, KS-Series, 4 mm x 70°, 30 cm O-Adapter, Speed-lock, Cystoscope SPY Cystoscope/Hysteroscope, Autoclavable, Speed-Lock, 4 mm x 30°, 30 cm SPY Cystoscope/Hysteroscope, Autoclavable, Speed-Lock, 4 mm x 12°, 30 cm SPY Cystoscope/Hysteroscope, Autoclavable, Speed-Lock, 4 mm x 0°, 30 cm SPY Cystoscope/Hysteroscope, Autoclavable, Speed-Lock, 4 mm x 70°, 30 cm SPY Cystoscope/Hysteroscope, Autoclavable, KS-Series, 4 mm x 12°, 30 cm SPY Cystoscope/Hysteroscope, Autoclavable, KS-Series, 4 mm x 0°, 30 cm

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)