BEUDAMED
    FDA Registration Active 🇨🇳 China

    Koo (Shanghai) Industries Co., Ltd

    Reg #: 3007963782 · FEI: 3007963782 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    32
    Establishment Types
    2
    Classifications
    9

    Registration Details

    Registration Name
    Koo (Shanghai) Industries Co., Ltd
    Registration Number
    3007963782
    FEI Number
    3007963782
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    100 Zhongde Road, Xiaokunshan Town
    City
    Songjiang Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K101136

    Owner / Operator

    Firm Name
    KOO MFG, INC.
    Operator Number
    9012237
    Address
    100 Zhongde Road, Dakun Indurstrial Park
    City
    Songjiang
    State
    Shanghai
    Postal Code
    201613
    Country
    CN
    Correspondent
    CHRISTOPHER - KOO

    US Agent

    Business Name
    Promedic, LLC
    Contact Name
    Matt Dryden
    Address
    131 Bay Point Dr NE
    City
    Saint Petersburg
    State
    FL
    ZIP
    33704
    Country
    US
    Email
    [email protected]
    Phone
    239 3076063

    Products

    Device Name Product Code
    Mask, Oxygen, Non-Rebreathing KGB
    Syringe, Irrigating (Non Dental) KYZ
    Mask, Oxygen BYG
    Cannula, Nasal, Oxygen CAT
    Mask, Gas, Anesthetic BSJ
    Tubing, Pressure And Accessories BYX
    Mask, Oxygen, Low Concentration, Venturi BYF
    Prostate Immobilizer Rectal Balloon PCT
    Holding Chambers, Direct Patient Interface NVP

    Proprietary Names

    Elongated Non-Rebreather Oxygen Mask OXYGEN MASK, NON-REBREATHING Inflation Syringe for Rectal Balloon MASK INFLATION BULB BULB SYRINGES Oxygen Mask with Reservoir Bag face tent Drainage Bag with 'T' connector Drainage Bag Aerosol Mask Oxygen Mask Tracheostomy Mask ZEPHIR MASK BLUESTAR PLUS FACE MASK FISIOJET AEROSOL DELUXE NASAL MOONLIGHT NASAL First Breath Nasal Oxygen Cannula with ETCO2 monitoring First Breath Nasal Oxygen Cannula with gas monitoring line, male luer connector, tubing, oxygen adapter First Breath Nasal Oxygen Cannula with male luer connector, tubing and oxygen connector First Breath Nasal Oxygen Cannula with female luer connector, tubing and oxgyen adapter First Breath Nasal Oxygen Cannula with gas monitoring line, female luer connector, tubing, oxygen adapter OXYGEN NASAL CANNULA FACE MASK ARIA BLOW MOLD MASK CRYSTAL ANESTHESIA MASK OXYGEN TUBING Venturi Mask Venturi Oxygen Mask Tracheostomy Venturi Oxygen Mask Prostate Caddy™

    Establishment Types

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