BEUDAMED
    Eu Mdd Eu Md Class 3 On The Market 🇩🇪 Germany

    Biotech Sterile Hip Endoprosthesis Systems

    Biotech GmbH · 🇩🇪 Germany
    View on EUDAMED
    Devices (same UDI-DI)
    1
    Certificates
    2
    Countries
    7
    Notified Bodies
    2

    Basic Information

    Primary DI
    D-4049852HI1CQSA
    Basic UDI-DI Code
    B-4049852HI1CQSA
    Reference
    4049852HI1CQ
    Device Types
    Single use Sterile Sterilization
    Regulation
    Eu Mdd
    Classification
    Eu Md Class 3
    Status
    On The Market
    Manufacturer
    Biotech GmbH

    Additional Description

    Biotech Sterile Hip Endoprosthesis Systems is a non-active surgical implant system for hip joint replacement. It is a modular device with several elements. It has a cemented or cementless design with device-specific accessories. It's a long-term, implantable device in class III. The device elements are made of metal (CoCr alloy, titanium alloy, stainless steel), plastic (UHMWPE) and ceramic raw materials.

    CND Nomenclature Codes

    Code Description
    P090803010101 PRIMARY IMPLANT CEMENTED METAL ACETABULAR CUPS
    P090803010102 PRIMARY IMPLANT CEMENTED POLYETHYLENE ACETABULAR CUPS, ONE-PIECE
    P090803010199 PRIMARY IMPLANT CEMENTED ACETABULAR CUPS - OTHER
    P090803010201 PRIMARY IMPLANT UNCEMENTED METAL ACETABULAR CUPS
    P090803010202 PRIMARY IMPLANT UNCEMENTED ONE-PIECE POLYETHYLENE ACETABULAR CUPS
    P090803010203 PRIMARY IMPLANT UNCEMENTED ONE-PIECE METAL ACETABULAR CUPS
    P090803010299 PRIMARY IMPLANT UNCEMENTED ACETABULAR CUPS - OTHER
    P09080302 HIP RESURFACING ACETABULAR COMPONENTS
    P0908030301 REVISION SURGERY CEMENTED ACETABULAR CUPS
    P0908030302 REVISION SURGERY UNCEMENTED ACETABULAR CUPS
    P090803040101 STANDARD POLYETHYLENE HIP PROSTHESES INSERTS
    P090803040102 ECCENTRIC POLYETHYLENE HIP PROSTHESES INSERTS
    P090803040103 RETENTIVE POLYETHYLENE HIP PROSTHESES INSERTS, ANTI-DISLOCATION
    P0908030402 HIP PROSTHESES CERAMIC ACETABULAR INSERTS
    P0908030403 HIP PROSTHESES METAL ACETABULAR INSERTS
    P0908030499 HIP PROSTHESES ACETABULAR INSERTS - OTHER
    P090803050101 CEMENTED DOUBLE-MOBILITY ACETABULAR CUPS
    P090803050102 UNCEMENTED DOUBLE-MOBILITY ACETABULAR CUPS
    P0908030502 DOUBLE-MOBILITY ACETABULAR COMPONENTS INSERTS
    P0908030601 PRE-ASSEMBLED ACETABULAR COMPONENTS WITH CERAMIC INSERT
    P0908030602 PRE-ASSEMBLED ACETABULAR COMPONENTS WITH POLYETHYLENE INSERTS
    P0908030699 PRE-ASSEMBLED ACETABULAR COMPONENTS - OTHER
    P090804010101 CEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, STRAIGHT
    P090804010102 CEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, ANATOMICAL
    P090804010105 CEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, FOR PRESERVATION
    P090804010106 CEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH MODULAR NECK, STRAIGHT
    P090804010107 CEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH MODULAR NECK, ANATOMICAL
    P090804010201 UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, STRAIGHT
    P090804010202 UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, ANATOMICAL
    P090804010205 UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, FOR PRESERVATION
    P090804010206 UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH MODULAR NECK, STRAIGHT
    P090804010207 UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH MODULAR NECK, ANATOMICAL
    P09080402 HIP RESURFACING FEMORAL COMPONENTS
    P090804030101 REVISION CEMENTED FEMORAL STEMS, WITH FIXED NECK
    P090804030102 REVISION CEMENTED FEMORAL STEMS, WITH MODULAR NECK
    P090804030201 REVISION UNCEMENTED FEMORAL STEMS, WITH FIXED NECK
    P090804030202 REVISION UNCEMENTED FEMORAL STEMS, WITH MODULAR NECK
    P09080404 LARGE RESECTIONS FEMORAL STEMS
    P090804050101 CERAMIC FEMORAL HEADS, PARTIAL HIP REPLACEMENT
    P090804050102 METAL FEMORAL HEADS, PARTIAL HIP REPLACEMENT
    P090804050199 FEMORAL HEADS FOR PRIMARY IMPLANT OF PARTIAL PROSTHESES - OTHER
    P090804050201 CERAMIC FEMORAL HEADS, TOTAL HIP REPLACEMENT
    P090804050202 METAL FEMORAL HEADS, TOTAL HIP REPLACEMENT
    P090804050299 FEMORAL HEADS FOR PRIMARY IMPLANT OF TOTAL PROSTHESES - OTHER
    P0908040503 HIP PROSTHESES, BI-ARTICULAR CUPS
    P0908040504 REVISION FEMORAL HEADS
    P09080406 ONE-PIECE FEMORAL PROSTHESES (STEM+HEAD)
    P09080407 MODULAR NECKS
    P090805 HIP PROSTHESES SPACERS
    P090899 HIP PROSTHESES - OTHER

    Certificates

    Type Number
    MDD Annex II Section 4 No. 5-905-204-2103
    MDD Annex II (excluding section 4) No. 5-903-200-2103

    Available In Countries

    🇧🇬 Bulgaria 🇨🇿 Czechia 🇩🇪 Germany 🇬🇷 Greece 🇭🇷 Croatia 🇭🇺 Hungary 🇹🇷 Türkiye

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