BEUDAMED
    18 results · 19ms · Sources: EU EUDAMED, US FDA

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    Lux-Lens GmbH

    Manufacturer
    🇩🇪 Germany

    LDN Labor Diagnostika Nord GmbH & Co. KG

    Manufacturer
    🇩🇪 Germany

    HSM 600 230 V with LAN

    Device
    EU MDR · Eu Md Class 1 ·HS DOMS GmbH·On the market

    HSM 600 120 V with LAN

    Device
    EU MDR · Eu Md Class 1 ·HS DOMS GmbH·On the market

    KARL STORZ ICG Imaging System with RUBINA® Lens

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. The Pentacam AXL is designed to take photos of the anterior segment of the eye, which includes the cornea, pupil, anterior chamber, and lens of the eye, to evaluate corneal shape, analyze condition of the lens (opaque crystalline lens), analyze the anterior chamber angle, analyze anterior chamber depth, analyze the volume of the anterior chamber, analyze anterior or posterior cortical opacity, analyze the location of cataracts (nuclear, sub capsular and/or cortical), using cross slit imaging with densitometry, corneal thickness, axial length, and white-to-white distance. The Pentacam AXL also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.

    FDA Enforcement
    Class II ·Terminated·Oculus Optikgeraete GMBH·February 28, 2018

    ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.

    FDA Enforcement
    Class II ·Ongoing·Carl Zeiss Meditec AG·May 4, 2022

    Contact Lens Service GmbH

    Importer
    🇩🇪 Germany

    Contact Lens Service GmbH

    Authorized representative
    🇩🇪 Germany·1 Manufacturer

    SEED Contact Lens Europe GmbH

    Importer
    🇩🇪 Germany

    SEED Contact Lens Europe GmbH

    Authorized representative
    🇩🇪 Germany·2 Manufacturers

    LDN Labor Diagnostika Nord GmbH & Co. KG

    Importer
    🇩🇪 Germany

    Arazy Group GmbH

    Authorized representative
    🇩🇪 Germany·30 Manufacturers·739 Devices

    Lens Reviewer

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·AkknaTek·1 device

    REP Europe GmbH

    Authorized representative
    🇩🇪 Germany·52 Manufacturers·263 Devices

    KTR Europe GmbH

    Authorized representative
    🇩🇪 Germany·135 Manufacturers·3461 Devices

    Humiss Beratung GmbH

    Authorized representative
    🇩🇪 Germany·152 Manufacturers·925 Devices

    MedNet EC-REP GmbH

    Authorized representative
    🇩🇪 Germany·464 Manufacturers·5263 Devices