BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MR Q supine

    DI: 03830074980000 · Model: MR Q supine · Meridian Medical d.o.o.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MR Q supine
    Primary DI
    03830074980000
    Version / Model
    MR Q supine
    Catalog Number
    780090
    Company Name
    Meridian Medical d.o.o.
    Labeler DUNS
    644472151
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-10-20
    Public Version
    2
    Public Version Date
    2025-11-24
    Public Version Status
    Update
    Public Device Record Key
    b1289312-cb6f-4331-bb40-4a60dbb6bac1

    Device Description

    The MR Q supine is a Q-switched Nd:YAG ophthalmic laser system designed for supine patient treatment, suitable for operating rooms and pediatric use. It delivers laser energy at 1064 nm with pulse durations around 4 ns. Energy levels range from 0.3 to 12 mJ (single pulse) and up to 32 mJ (triple pulse). The device features electronically controlled treatment offset settings: anterior (150 µm, 300 µm) and posterior (0 µm, 100 µm, 200 µm, 300 µm), enhancing precision and safety. The laser has a super Gaussian beam profile and dual red diode aiming beams (635 nm) for accurate targeting. It includes Haag-Streit binoculars with tilt adjustment (0–210 degrees), joystick control, and optional footswitch. The integrated CSO 9800 LED slit lamp (Zeiss type) offers magnification from 6x to 40x. The MR Q supine is compatible with various operating tables and includes fixtures for treating young children. Safety features include automatic wheel locking, keypad access, and audible alarms for offset selection. The system is air-cooled and compliant with IEC 60601-1, EN 60601-1-2, and MDD 93/42/EEC standards. Indications for use include posterior capsulotomy and peripheral iridotomy. The MR Q supine is designed to deliver precise and effective ophthalmic laser treatments in a compact and ergonomic format.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HQF Laser, Ophthalmic

    GMDN Terms

    Code Name
    62197 Ophthalmic solid-state laser system

    Identifiers

    Type ID
    Primary 03830074980000