BEUDAMED
    22 results · 33ms · Sources: EU EUDAMED, US FDA

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    Medimaps Group SA

    Manufacturer
    🇨🇭 Switzerland·2 Basic UDI-DIs·3 Devices

    Medimaps Group SA

    FDA registration
    Medimaps Group SA·1 product·🇨🇭 Switzerland

    TBS iNsight

    FDA UDI
    medimaps group SA·B214OSTBSI3100·TBS iNsight is a software provided for use as a...

    TBS iNsight

    FDA UDI
    medimaps group SA·B214OSTBSI3120·TBS iNsight is a software provided for use as a...

    TBS iNsight

    FDA UDI
    medimaps group SA·B214OSTBSI30·TBS iNsight is a software provided for use as a...

    TBS iNsight

    FDA UDI
    medimaps group SA·B214OSTBSI3110·TBS iNsight is a software provided for use as a...

    Medimaps TBS iNsight

    FDA UDI
    medimaps group SA·B214OSTBSI0·TBS iNsight is a software provided for use as a...

    TBS iNsight

    FDA UDI
    medimaps group SA·B214OSTBSI303·TBS iNsight is a software provided for use as a...

    TBS iNsight

    FDA UDI
    medimaps group SA·B214OSTBSIV400·TBS iNsight is a software application provided ...

    Phantom

    FDA UDI
    medimaps group SA·B214OSPTM3·

    TBS OSTEO

    Device
    EU MDR · Eu Md Class 2a ·Medimaps Group SA·On the market·32 countries

    TBS Osteo

    Device
    EU MDR · Eu Md Class 1 ·Medimaps Group SA·On the market

    TBS OSTEO

    Device
    EU MDR · Eu Md Class 2a ·Medimaps Group SA·On the market·11 countries

    TBS Calibration Phantom

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Medimaps Group SA·1 device

    TBS iNsight

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Medimaps Group SA·2 devices

    Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2, (2) V3.1.1, (3) V3.1.0, (4)V3.0.0 Product Description: TBS iNsight is a class II Medical Device software that is installed on bone densitometers for analysis of bone microarchitecture and bone health management Component: No

    FDA Enforcement
    Class II ·Ongoing·Medimaps Group·March 12, 2025

    TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.

    FDA Enforcement
    Class II ·Terminated·Medimaps Group·November 16, 2016

    Med-Imaps SASU

    Authorized representative
    🇫🇷 France·1 Manufacturer·3 Devices

    TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.

    FDA Recall
    Terminated ·Medimaps Group Fongit Chemin des Aulx 18 Plan-les-Ouates Switzerland·Product code KGI·October 3, 2016

    Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2, (2) V3.1.1, (3) V3.1.0, (4)V3.0.0 Product Description: TBS iNsight is a class II Medical Device software that is installed on bone densitometers for analysis of bone microarchitecture and bone health management Component: No

    FDA Recall
    Open, Classified ·Medimaps Group Fongit Chemin des Aulx 18 Plan-les-Ouates Switzerland·Product code KGI·February 3, 2025