BEUDAMED
    10,000 results · 96ms · Sources: EU EUDAMED, US FDA

    279276-2018-CE-IND-NA-PS

    Certificate
    MDD Annex II Section 4·Sahajanand Medical Technologies Limited·DNV Product Assurance AS·102 Basic UDI-DIs

    HU/CA01/54096/13

    Certificate
    IVDD Annex III Section 6·Biolab Zrt·NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC)·1 Basic UDI-DI

    HX 1191616-1

    Certificate
    IVDR QMS·IMMUCOR Medizinische Diagnostik GmbH·TÜV Rheinland LGA Products GmbH

    IX 1191616-11

    Certificate
    IVDR Technical Documentation·IMMUCOR Medizinische Diagnostik GmbH·TÜV Rheinland LGA Products GmbH

    HD 2181802-1

    Certificate
    MDD Annex II (excluding section 4)·Gansu Constar Technology Group Co., Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

    10924233

    Certificate
    MDD Annex II (excluding section 4)·Gansu Constar Technology Group Co., Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

    HL60145538

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·GB Lifecare Co., Ltd.·TÜV Rheinland LGA Products GmbH·2 Basic UDI-DIs

    Pediatric Esophageal Atresia Anastomosis Device

    FDA classification
    FDA Class 3 ·Pediatric Esophageal Atresia Anastomosis Device

    Cyclosporine

    FDA Pre-Market Approval
    FDA Class 2 ·EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·Dimension Vista FPSA Flex reagent cartridge (K6452)

    Kit, Assay, Progesterone Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·Dimension FPSA Flex Reagent Cartridge

    Lens, Contact (Polymethylmethacrylate)

    FDA Pre-Market Approval
    FDA Unclassified ·PARAPERM O2 CONTACT LENS CLEAR & BLUE

    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

    FDA Pre-Market Approval
    FDA Class 2 ·Dimension TPSA Flex reagent cartridge (RF451)

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·Dimension FPSA Flex reagent cartridge (RF451)

    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

    FDA Pre-Market Approval
    FDA Class 2 ·Dimension Vista TPSA Flex reagent cartridge (K6451)