BEUDAMED
    19 results · 17ms · Sources: EU EUDAMED, US FDA

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    ONE MAN KIT OKS 2511-1

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Eldon Biologicals A/S·On the market

    ONE MAN KIT OKS 2511-1

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·Eldon Biologicals A/S·1 device

    Reapplix A/S

    Manufacturer
    🇩🇰 Denmark·1 Basic UDI-DI·1 Device·Eurofins Electric & Electronics Finland Oy

    BrainCapture ApS

    Manufacturer
    🇩🇰 Denmark·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ

    3C Patch Device

    Device
    EU MDD · Eu Md Class 2a ·Reapplix A/S·On the market·5 countries

    SnorBan DK ApS

    Importer
    🇩🇰 Denmark·1 Manufacturer

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·October 30, 2024

    BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN

    FDA Enforcement
    Class II ·Terminated·B-K Medical A/S·August 10, 2016

    bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·January 31, 2024

    Bureau Medica Intercert DK

    Authorized representative
    🇩🇰 Denmark·2 Manufacturers

    3C Patch Device

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Reapplix A/S·1 device

    C-01-1210-718-19

    Certificate
    MDD Annex II (excluding section 4)·Reapplix A/S·Eurofins Electric & Electronics Finland Oy·1 Basic UDI-DI

    MDR-007

    Certificate
    MDR QMS·BrainCapture ApS·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ