BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Leadset 5-Lead Chest DIN, AAMI

    Reg #: 3004035727 · FEI: 3004035727 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    20
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BERND RICHTER GMBH
    Registration Number
    3004035727
    FEI Number
    3004035727
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Hansestrasse 4
    City
    Wipperfuerth North Rhine-Westphalia
    Country
    DE

    Owner / Operator

    Firm Name
    Bernd Richter GmbH
    Operator Number
    10046701
    Address
    Hansestrasse 4
    City
    Wipperfuerth
    State
    North Rhine-Westphalia
    Postal Code
    51688
    Country
    DE
    Correspondent
    Christopher Kott

    US Agent

    Business Name
    Bernd Richter USA, Inc.
    Contact Name
    David Krohn
    Address
    2097 Iglehart Ave.
    City
    Saint Paul
    State
    MN
    ZIP
    55104
    Country
    US
    Email
    [email protected]
    Phone
    651 4420278

    Products

    Device Name Product Code
    Cable, Electrode IKD

    Proprietary Names

    Leadset 5-Lead Chest DIN, AAMI Leadset 5-Lead Limb DIN, AAMI 4-lead modular trunk cable (AAMI) Tempus Pro 5-lead ECG Cable (AAMI) 6ft Tempus Pro 3-lead ECG Cable (AAMI) 6ft Tempus Pro 3-lead ECG Cable (AAMI) 8ft 6-lead ECG chest leads (AAMI) Tempus Pro 3-lead Neonatal ECG Cable (AAMI) 6ft Tempus Pro 12-lead ECG Cable (AAMI) 8ft 5-Lead ECG Cable (IEC) 6ft 3-Lead Neo ECG Modular Cable (IEC) 6ft 5-Lead ECG Cable (IEC) 8ft 4-Lead ECG Modular Cable (IEC) 8ft 6-Lead ECG Limb Leads (IEC) Tempus Pro 12-lead ECG Cable (AAMI) 6ft 12-Lead ECG Cable (IEC) 8ft 3-Lead ECG Cable (IEC) 8ft 12-Lead ECG Cable (IEC) 6ft 3-Lead ECG CBL (IEC) 6ft Tempus Pro 5-lead ECG Cable (AAMI) 8ft

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)