BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    APPS-HEALTH01

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560; 4) Versana Premier Lotus 5PP, Model/Catalog Number 5938561; 5) Versana Premier R3 VA Vet, Model/Catalog Number 5946387; 6) Versana Premier R3 VS Vet, Model/Catalog Number 5946481. 7) Versana Premier R3 Expert, Model/Catalog Number 5946950; 8) Versana Premier R3, Model/Catalog Number 5946951; 9) Versana Premier R3 Pro, Model/Catalog Number 5946952; 10) Versana Premier R3 Elite, Model/Catalog Number 5946953; 11) Versana Premier R3 Plus, Model/Catalog Number 5946954; 12) Versana Premier R3 Ultra, Model/Catalog Number 5946955; 13) Versana Premier R3 Max, Model/Catalog Number 5946956; 14) Versana Premier R3 Super, Model/Catalog Number 5946957; 15) Versana Premier R3 VS India, Model/Catalog Number 5948398; 16) Versana Premier R3 VA India, Model/Catalog Number 5948399; diagnostic ultrasound system

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems China Co., Ltd.·July 2, 2025

    iBreathe APP

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·FEELLIFE HEALTH INC.·1 device

    ECG App

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·Huawei Device Co., Ltd.·1 device

    Elastic Placers

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·ASTAR ORTHODONTICS INC.·1 device

    Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Continuous Glucose Monitoring System APP

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·Changsha Sinocare Inc.·1 device

    G1 081711 0023

    Certificate
    MDD Annex II (excluding section 4)·Shanghai MicroPort EP MedTech Co., Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

    G1 081711 0023

    Certificate
    MDD Annex II (excluding section 4)·Shanghai MicroPort EP MedTech Co., Ltd.·TÜV SÜD Product Service GmbH·3 Basic UDI-DIs