BEUDAMED
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    CJI LTD.

    FDA registration
    CJI LTD.·5 products·🇹🇼 Taiwan

    Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.

    FDA Enforcement
    Class II ·Terminated·EMG Technology Co., Ltd.·September 24, 2014

    CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)

    FDA Enforcement
    Class II ·Ongoing·Kung Shin Plastics Co. Ltd.·March 12, 2025

    CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)

    FDA Enforcement
    Class II ·Ongoing·Kung Shin Plastics Co. Ltd.·March 12, 2025

    Lagis Enterprise Co., Ltd.

    System producer
    🇹🇼 Taiwan

    CLNB1639 - K604127

    Certificate
    MDD Annex II (excluding section 4)·BOMEI Co.,Ltd·SGS Belgium NV·3 Basic UDI-DIs

    Non Sterile Orthodontic Anchorage Screw

    Certificate
    MDD Annex II (excluding section 4)·BOMEI Co.,Ltd·SGS Belgium NV·1 Basic UDI-DI

    04719873183265

    Certificate
    MDD Annex II (excluding section 4)·BOMEI Co.,Ltd·SGS Belgium NV·1 Basic UDI-DI

    CLNB1639-K604127

    Certificate
    MDD Annex II (excluding section 4)·BOMEI Co.,Ltd·SGS Belgium NV·13 Basic UDI-DIs

    12429-2018-CE-RGC-NA-PS

    Certificate
    MDD Annex II (excluding section 4)·iWEECARE Co., Ltd.·DNV Product Assurance AS·1 Basic UDI-DI

    CLNB1639 - K604127

    Certificate
    MDD Annex II (excluding section 4)·BOMEI Co.,Ltd·SGS Belgium NV·272 Basic UDI-DIs

    CE614409

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·iXensor Co., Ltd.·BSI Group The Netherlands B.V.·1 Basic UDI-DI

    CE 614409

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·iXensor Co., Ltd.·BSI Group The Netherlands B.V.·4 Basic UDI-DIs

    TW23/00000774

    Certificate
    MDR QMS·Asia Connection Co., Ltd.·SGS Belgium NV

    V1 063505 0063

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·OK biotech co., Ltd·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

    G1 102623 0002

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

    10146-2017-CE-RGC-NA-PS

    Certificate
    MDD Annex V·YAAN DEVICE CO., LTD·DNV Product Assurance AS·17 Basic UDI-DIs

    10146-2017-CE-RGC-NA-PS

    Certificate
    MDD Annex V·YAAN DEVICE CO., LTD·DNV Product Assurance AS·1 Basic UDI-DI

    TW19/20066

    Certificate
    MDD Annex II (excluding section 4)·APOZA ENTERPRISE CO., LTD.·SGS Belgium NV·2 Basic UDI-DIs

    TW/19/20066

    Certificate
    MDD Annex II (excluding section 4)·APOZA ENTERPRISE CO., LTD.·SGS Belgium NV·1 Basic UDI-DI