BEUDAMED
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    REUMAGEN ASL

    FDA 510(k)
    FDA Class 1 ·Microbiology

    GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c) 95 Multichroma 20LA1, REF GC00130; d) 95 Multichroma 24LC2, REF GC00090; e) 95 Multichroma 24LA1, REF GC00113; f) 95 Multichroma 16LB2, REF GC00131; g) 95 Multichroma 14LA2, REF GC00157; h) 95 Multichroma 20LB2, REF GC00098; i) 95 Multichroma 20LBL2, REF GC00114; j) 95 Multichroma 16LA3,5, REF GC00132; k) 95 Multichroma 14LA1, REF GC00158; l) 95 Multichroma 24LB1, REF GC00099; m) 95 Multichroma 20LA3,5, REF GC00115; n) 95 Multichroma 16LA3, REF GC00133; o) 95 Multichroma 16LC2, REF GC00091; p) 95 Multichroma 14LBL2, REF GC00134; q) 95 Multichroma 24LBL2, REF GC00092; r) 95 Multichroma 24LA3,5, REF GC00101; s) 95 Multichroma 20LA3, REF GC00117; t) 95 Multichroma 14LB1, REF GC00135; u) 95 Multichroma 24LB2, REF GC00094; v) 95 Multichroma 20LA2, REF GC00119; w) 95 Multichroma14LA3,5, REF GC00137; x) 95 Multichroma 14LC2, REF GC00095; y) 95 Multichroma 24LA3, REF GC00104; z) 95 Multichroma14LA3, REF GC00138 ; used in the manufacture of dentures.

    FDA Enforcement
    Class II ·Ongoing·GRAPHENANO DENTAL SL·March 6, 2024

    MED 31332-1

    Certificate
    MDD Annex II (excluding section 4)·Noventure SL·KIWA CERMET ITALIA S.P.A.·1 Basic UDI-DI

    CSQ001623

    Certificate
    MDR QMS·Noventure SL·ISTITUTO SUPERIORE DI SANITA'

    CVD002323

    Certificate
    MDR Technical Documentation·Noventure SL·ISTITUTO SUPERIORE DI SANITA'

    170771265

    Certificate
    MDD Annex II (excluding section 4)·Noruco SL·DQS Medizinprodukte GmbH·1 Basic UDI-DI

    CVD 0023-23

    Certificate
    MDR Technical Documentation·Noventure SL·ISTITUTO SUPERIORE DI SANITA'·2 Basic UDI-DIs

    2084/MDD

    Certificate
    MDD Annex II (excluding section 4)·Osteophoenix SL·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.·18 Basic UDI-DIs

    1984-MDD-18-497

    Certificate
    MDD Annex II Section 4·PROTEOS BIOTECH SL·Kiwa Belgelendirme Hizmetleri A.Ş.·1 Basic UDI-DI

    MED31577

    Certificate
    MDD Annex V·Cuantum Medical Cosmetics SL·KIWA CERMET ITALIA S.P.A.·2 Basic UDI-DIs

    2195-MED-2113101, 2195-MED-2113101-D01

    Certificate
    MDD Annex II Section 4·Skin Tech Pharma Group, SL·Szutest Uygunluk Değerlendirme A.Ş.·1 Basic UDI-DI

    ES19/86902

    Certificate
    MDD Annex V·AIR LIQUIDE HEALTHCARE ESPAÑA, SL·SGS Belgium NV·7 Basic UDI-DIs

    Osteophoenix sl

    System producer
    🇪🇸 Spain

    SENDAL, SL

    System producer
    🇪🇸 Spain

    CERAROOT SL

    System producer
    🇪🇸 Spain

    C.V. MEDICA, SL

    System producer
    🇪🇸 Spain

    MIKROMIC MEDICAL SL

    System producer
    🇪🇸 Spain

    FUDLONG SL

    Authorized representative
    🇪🇸 Spain·2 Manufacturers

    MAZULI, SL

    Authorized representative
    🇪🇸 Spain·1 Manufacturer

    Charmossas SL

    Authorized representative
    🇪🇸 Spain