BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Ambu aScope 5 Broncho HD 5/2.2 Sampler Set

    Reg #: 3004040397 · FEI: 3004040397 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AMBU SDN.BHD.
    Registration Number
    3004040397
    FEI Number
    3004040397
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    LOT 69-B, Lintang Bayan Lepas 6, Phase IV
    City
    PENANG Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K223782

    Owner / Operator

    Firm Name
    AMBU A/S
    Operator Number
    8010067
    Address
    13 BALTORPBAKKEN, --
    City
    BALLERUP
    State
    DK-NOTA
    Postal Code
    DK-2750
    Country
    DK

    US Agent

    Business Name
    Ambu Inc
    Contact Name
    Sanjay Parikh
    Address
    6721 Columbia Gateway Drive, Suite 200
    City
    Columbia
    State
    MD
    ZIP
    21046
    Country
    US
    Email
    [email protected]
    Phone
    410 7686464 ext. 1136

    Products

    Device Name Product Code
    Bronchoscope (Flexible Or Rigid) EOQ

    Proprietary Names

    Ambu aScope 5 Broncho HD 5/2.2 Sampler Set Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)