BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    OLDELFT B.V.

    Reg #: 1000601180 · FEI: 1000601180 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    4

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    Registration Details

    Registration Name
    OLDELFT B.V.
    Registration Number
    1000601180
    FEI Number
    1000601180
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Heertjeslaan 10
    City
    Delft Zuid-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K173341

    Owner / Operator

    Firm Name
    Oldelft B.V.
    Operator Number
    10047391
    Address
    Heertjeslaan 10
    City
    Delft
    State
    Zuid-Holland
    Postal Code
    2629 JG
    Country
    NL
    Correspondent
    Rob Smallenburg

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Catheter, Ultrasound, Intravascular OBJ

    Proprietary Names

    S7-3t compact 10T-D microMulti TEE Probe S8-3t S7-3t 171V400 miniMulti TEE Probe , supplied by Oldelft to Siemens (Siemens model V7M)

    Establishment Types

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