BEUDAMED
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    SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD

    FDA 510(k)
    FDA Class 1 ·Dental

    Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant

    FDA Enforcement
    Class II ·Ongoing·MED-EL Elektromedizinische Gereate, Gmbh·July 24, 2024

    SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external battery pack used to power one MED-EL SONNET control unit. It can be worn on the upper body or the hip using different SONNET Mini Battery Pack Cable lengths to connect the SONNET Mini Battery Pack to one processor unit.

    FDA Enforcement
    Class II ·Terminated·MED-EL Elektromedizinische Gereate, Gmbh·March 8, 2017

    MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.

    FDA Enforcement
    Class II ·Terminated·MED-EL Elektromedizinische Gereate, Gmbh·August 14, 2019

    MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO +FLEX28; c. Mi1000 CONCERTO PIN +FLEXsoft; d. Mil000 CONCERTO +Standard; e. Mil000 CONCERTO +Medium; f. Mi1000 CONCERTO PIN +Standard; g. M11000 CONCERTO +Compressed Product Usage: The Mi1000 CONCERTO Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.

    FDA Enforcement
    Class II ·Terminated·MED-EL Elektromedizinische Gereate, Gmbh·August 14, 2019

    MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. SONATAti100 Standard Product Usage: The SONATATIi100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.

    FDA Enforcement
    Class II ·Terminated·MED-EL Elektromedizinische Gereate, Gmbh·August 14, 2019

    DD 60141729 0001

    Certificate
    MDD Annex V·MED TRUST Handelsges.m.b.H.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

    DD601417290001

    Certificate
    MDD Annex V·MED TRUST Handelsges.m.b.H.·TÜV Rheinland LGA Products GmbH·24 Basic UDI-DIs

    MED TRUST Handelsges.m.b.H.

    System producer
    🇦🇹 Austria

    DIPRO med GmbH

    Authorized representative
    🇦🇹 Austria

    Alfamed Medizinprodukte GmbH

    Importer
    🇦🇹 Austria·3 Manufacturers

    MSP Medizintechnik GmbH

    Importer
    🇦🇹 Austria·2 Manufacturers

    Baar-Baarenfels Med Consulting GmbH

    Authorized representative
    🇦🇹 Austria

    DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H

    Importer
    🇦🇹 Austria·4 Manufacturers

    MED TRUST Handelsges.m.b.H.

    Manufacturer
    🇦🇹 Austria·25 Basic UDI-DIs·25 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

    Biolux Technology GmbH

    Manufacturer
    🇦🇹 Austria·4 Basic UDI-DIs·5 Devices·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ and SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ

    JOANNEUM RESEARCH Forschungsgesellschaft mbH

    Manufacturer
    🇦🇹 Austria·12 Basic UDI-DIs·17 Devices·SLG PRÜF UND ZERTIFIZIERUNGS GMBH, SLG PRÜF UND ZERTIFIZIERUNGS GMBH, and MDC MEDICAL DEVICE CERTIFICATION GMBH

    W&H Dentalwerk Bürmoos GmbH

    Manufacturer
    🇦🇹 Austria·11 Basic UDI-DIs·48 Devices·DQS Medizinprodukte GmbH and DQS Medizinprodukte GmbH

    SteadySense GmbH

    Manufacturer
    🇦🇹 Austria·2 Basic UDI-DIs·5 Devices·SLG PRÜF UND ZERTIFIZIERUNGS GMBH

    g.tec medical engineering GmbH

    Manufacturer
    🇦🇹 Austria·1 Basic UDI-DI·1 Device·TÜV SÜD Product Service GmbH