BEUDAMED
    12 results · 27ms · Sources: EU EUDAMED, US FDA

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    ALCIS

    Manufacturer
    🇫🇷 France

    FCI SAS

    FDA registration
    FCI SAS·30 products·🇫🇷 France

    RISKONTROL DCI

    Device
    EU MDR · Eu Md Class 1 ·ACTEON MANUFACTURING·On the market·21 countries

    FCI FRANCE CHIRURGIE INSTRUMENTATION

    FDA registration
    FCI FRANCE CHIRURGIE INSTRUMENTATION·31 products·🇫🇷 France

    MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·August 18, 2021

    DENTAL COMPONENTS EUROPE

    Authorized representative
    🇫🇷 France·1 Manufacturer·2 Devices

    The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with polysiloxane. CARDIOXYL sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOXYL sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for double armed (36 sutures), 24 units for ligatures (24 reels), 12 packs for double armed (5 Green/5 White) (120 sutures).

    FDA Enforcement
    Class II ·Terminated·Peters Surgical·October 1, 2014

    The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate)] braids, coated, with or without PLEDGETS of different sizes. CARDIOFLON Evolution sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOFLON Evolution sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures, except for some diameters. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for single or double armed (36 sutures), 24 units of ligatures (24 reels), 12 packs for double armed (10 Green or 5 Green/5 White) (120 sutures).

    FDA Enforcement
    Class II ·Terminated·Peters Surgical·October 1, 2014

    Momentum LC

    Authorized representative
    🇫🇷 France

    LABORATOIRE DE CONTACTOLOGIE APPLIQUEE - LCA

    System producer
    🇫🇷 France

    LTI TESTING & CERTIFICATION FRANCE S.A.S.

    Authorized representative
    🇫🇷 France

    France Chirurgie Instrumentation SAS (FCI S.A.S.)

    System producer
    🇫🇷 France