BEUDAMED
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    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·PRP Science Co., Ltd.·1 device

    Ecolla

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·PRP Science Co., Ltd.·1 device

    Glucose Kit (GOD-PAP Method)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·1 device

    Triglycerides Kit (GPO–PAP Method)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·1 device

    Phencyclidine （PCP） Rapid Test（Urine）

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Xiamen Biotime Biotechnology Co., Ltd.·1 device

    AIA-PACK PAP CALIBRATOR SET

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Tosoh Corporation·1 device

    Triglycerides Kit (GPO-PAP Method)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·MedicalSystem Biotechnology Co., Ltd.·1 device

    Reader, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·ThinPrep Integrated Imager

    IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    System, Hemodynamic, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Cordella Pulmonary Artery Sensor System (CorPASS)

    ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Pap Smear Kit

    FDA classification
    FDA Class 2 ·Pap Smear Kit

    Positive Expiratory Pressure (PEP) Therapy device

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Intersurgical Ltd·9 devices

    Positive Airway Pressure System(PAP System)

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Resvent Medical Technology Co., Ltd·1 device

    Total Cholesterol Kit (CHOD–PAP Method)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·1 device

    Uric Acid Kit (Uricase-PAP Method)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·1 device

    Creatinine Kit (Sarcosine Oxidase –PAP Method)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·1 device

    Phencyclidine (PCP) Rapid Test Kit (Urine)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·1 device

    Phencyclidine (PCP) Rapid Test Kit (Urine)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·1 device