BEUDAMED
    MDR MDR QMS Issued

    TNP/MDR/0029/5488/2025

    Manufacturer: Cutera, Inc.
    Basic UDI-DIs
    0
    Scopes
    28
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    Ver. 01
    1314
    Valid for 1314 days
    Expiry: January 12, 2030

    Basic Information

    Number
    TNP/MDR/0029/5488/2025
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    January 13, 2025
    Expiry Date
    January 12, 2030
    Revision
    Ver. 01
    Manufacturer
    Cutera, Inc.

    Certificate Lifecycle

    January 13, 2025 January 12, 2030

    Device Characteristics

    Intended Medical Purpose

    Scopes

    28 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Group Class IIb

    Medical laser

    Quality Procedure Scope

    Device Group Class IIb

    Micro lens array

    Quality Procedure Scope

    Device Group Class IIb

    Laser system

    Quality Procedure Scope

    Device Group Class IIb

    Laser system xeo/xeo SA handpieces

    Quality Procedure Scope

    Device Group Class IIb

    Laser system xeo+/xeo+ SA handpieces

    Quality Procedure Scope

    Device Group Class IIb

    Laser system excel V+ handpieces

    Basic UDI-DIs

    This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.