BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    macu4 GmbH

    Reg #: 3042101018 · FEI: 3042101018 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    76
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    macu4 GmbH
    Registration Number
    3042101018
    FEI Number
    3042101018
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Buecklestr. 3
    City
    Konstanz Baden-Wurttemberg
    Country
    DE

    Owner / Operator

    Firm Name
    macu4 GmbH
    Operator Number
    10094184
    Address
    Buecklestr. 3
    City
    Konstanz
    State
    Baden-Wurttemberg
    Postal Code
    78467
    Country
    DE

    US Agent

    Business Name
    MCRA, LLC
    Contact Name
    Hannah Irwin
    Address
    803 7th St Nw
    City
    Washington
    State
    DC
    ZIP
    20001
    Country
    US
    Email
    [email protected]
    Phone
    202 5525820

    Products

    Device Name Product Code
    Prosthesis, Thigh Socket, External Component ISS
    Unit, Wrist, External Limb Component, Mechanical ISZ
    Adaptor, Recreational ILT

    Proprietary Names

    Lumo Spacer, STD-B Lumo Module Connector Lumo Spacer, STD-C Lumo Spacer, STD-E Lumo Spacer, STD-D Lumo Spacer, STD-A Explorer Ring EXP Explorer Swim Module SML without spacer Explorer Ball Module STD with spacer Explorer Pinch Module STD without spacer Explorer Ring STD Explorer Pinch Module spacer Explorer Ball Module SML with spacer Explorer Twin Module LRG without spacer Explorer Twin Module LRG with spacer Explorer Ball Module STD without spacer Explorer Ball Module SML without spacer Explorer Bike Module STD without spacer Explorer Swim Module STD without spacer Explorer Hold Module STD without spacer Explorer Twin Module STD with spacer Explorer Bike Module STD with spacer Explorer Hold Module spacer Explorer Twin Module STD without spacer Lynk Clic Lock Adapter Lynk Clic Lock Head 70°, STD Lumo Cuff, STD-SML-B Lynk Cover, SML Lynk Velcro Closure, Size: MED, Arm side: Left Lynk Clic Head 0° Lumo Cuff, STD-MED-E Lynk Push Module standard Lynk Velcro Closure, Size: MED, Arm side: Right Lynk Clic Head 360° Lynk Clic Lock Head 0°, ELLIPSE Lynk Velcro Closure, Size: XS, Arm side: Right Lumo Cuff, STD-MED-B Lumo Cuff, STD-MED-D Lumo Cuff, STD-SML-D Lynk Clic Lock Module Lynk Clic Module Lynk Cuff short-extra small Lynk Cover, MED Lynk Cuff short-small Lynk Velcro Closure, Size: LRG, Arm side: Left Lumo Cuff, STD-SML-C Lumo Cuff, STD-SML-A Lynk Clic Lock Head 360°, FLAT Lumo Cuff, STD-SML-E Lumo Clamp, STD Lynk Clic Lock Head 70°, ELLIPSE Lynk Cuff standard-medium Lynk Cover, LRG Lynk Hook Module standard Lynk Cuff short-large Lumo Shovel, STD Lynk Cuff standard-large Lynk Hold Lock Module Lynk Clic Lock Head 360°, STD Lynk Clic Lock Head 360°, ELLIPSE Lynk Velcro Closure, Size: SML, Arm side: Right Lynk Velcro Closure, Size: LRG, Arm side: Right Lynk Clic Lock Head 0°, STD Lynk Cuff short-medium Lynk Clic Adapter Lynk Clic Lock Head 0°, FLAT Lynk Velcro Closure, Size: SML, Arm side: Left Lumo Cuff, STD-MED-A Lynk Cuff standard-small Lynk Clic Lock Head 70°, FLAT Lynk Clic Head 70° Lumo Cuff, STD-MED-C Lumo Roll, STD Lynk Hold Module standard Lumo Hold, Lock Lynk Velcro Closure, Size: XS, Arm side: Left

    Establishment Types

    Manufacture Medical Device