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  • Conmed Advantage D3000

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    Paulina Lekszycka
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    This document declares that various medical devices produced by ConMed Corporation meet the provisions of the European Medical Device Directive 93/42/EEC. An Annex II, Clause 3 certification was issued by TUV Product Service, the notified body, to verify compliance. MDSS GmbH was appointed as the European Authorised Representative to act on behalf of ConMed Corporation within the EU.

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    954. Conmed Advantage D3000

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    This document declares that various medical devices produced by ConMed Corporation meet the provisions of the European Medical Device Directive 93/42/EEC. An Annex II, Clause 3 certification was issued by TUV Product Service, the notified body, to verify compliance. MDSS GmbH was appointed as the European Authorised Representative to act on behalf of ConMed Corporation within the EU.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    9 views1 page

    Conmed Advantage D3000

    Uploaded by

    Paulina Lekszycka
    This document declares that various medical devices produced by ConMed Corporation meet the provisions of the European Medical Device Directive 93/42/EEC. An Annex II, Clause 3 certification was issued by TUV Product Service, the notified body, to verify compliance. MDSS GmbH was appointed as the European Authorised Representative to act on behalf of ConMed Corporation within the EU.

    Copyright:

    © All Rights Reserved
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    of 1

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    1,°'l"Tr :.AClt..:-0'1:$LOC..A.TEDAl:
    DECLARATION OF CONFORMITY \.:TIG.A NCV.: �ORH' l!5A
    NEV-.• H>.�o-n� Nt\',' ','c� LISA.
    RQj,tE. N.:WYOAK 1./SA
    CERT!FICATE V'EN"./E"A. COLGR.a.;JO USA
    'EL P"6.0. 7o;,-6 US/1
    JU,l,,,TJE:l. CHfJ-l UAHli,t.. �lO'.JCC

    We. CoNMEo Corporation, 525 French Road, Utica, NY 13501 USA, accordlng lo EN45014, declare with sofe responsibility, thal our medical oevices:

    Aspir,JtQr, l!0-208] - Clas5 [fa Hedical Oe,•ices Electrosurgieo! 'Jnit, MonopolarfßiPQlar. Argon-Enhar.cea Coagulatia11 [ 18-2)2} -
    Caol�/Leads, Electrosurgical Uoit (ll-4%J - Class l!b M�lrnl oe�ICe5 Cla�s II b t-1€!-dlcat D evlce
    Ca.nnuldE, Other {15-206] - C!ass 11a Medical Devices Elevators, Uterine [ 15-6 77) - C\as; lla Medic.a\ DE''lrce
    cathete,, Cno/3n9iogr.1phy [16-429) - Cl�ss lla Medicil Oevlces Forceps, Ele-..'1rosurgra.1 [11-502) - Class IIb Medial Devices
    Cllp Applien [l!Nl9◄] - (lass Jlt} Me<lkal Device Nee<1le.s, Pneumoperitoneol \ 12-7 SOJ - Class lla Meci,cal Devices
    Oressi119, Other [15-216] - Cfass lla Medic.al Device Pressure lnfusais (IJ-100j- Class fü Medlcal Devices
    Electrodes, Oefrbril!ation l 15-033] - C'a,s lla Medical Devices Rerractoi., Aboomlnal {13-375] - Clilss lla Medical D��i(es
    Electrod�, Electrosur(Jlcal, Acti�e [ 16-860] - Clas.s IIb Medlcal Devices Retractors, Vaginal [ll-392] - C\ass Ha Medlcal Devices
    Bectrodes, Electrosurglcal, Active, faat�cintrol\ed [16-206)- (lass llb MedJC�I Dev;ces Spedmen Containers (13-655] - Cla�s Ila Medical Oe-vrces
    Ele(_ifodes, Ek:ctro�urQical, Active, Hand-controlled [IH9'l] - Class ltb Medical Devices Soctioo lnig ators f 1 J-845 l - Class Ila Medl<al Devfce�
    Electrodes, Transrutaneous, Electr1cal Nerve Stimulation jl7-191] - C�ss Ila Medic.al Devices Suctio111lps, El&."trosurolcal \15-31�} - Clas� l!J Med·cal Oevites
    Eleoro5UrQ1Co! Unit Adapters, C.ible (l H93j -Class llb Medica! Devices Suture V1üts, Autornalic ( 15--065j - Class llb Medical Devices
    Electrosurgrcal Unlt D3000, Mon01)olar/61polar (16-BJ] -Cl<!ss Hb Medk:al Device Suture Unit�, Other (16·2643 - Class mi Medical Oe-.�ces
    Trorars [l�-154] - Class na Medical De1qce:s

    meet, (where applicable), the provisions of Council DirBctive 9:J/42/EEC pertaining lo medical devices which app!y to lhem. The obligation as lald down in
    Annex Hof tne 93(42/EEC are fulfüled via Annex II, Ciause 3 certification issued by TUV Producl Service, Nolified Body No. 0123.

    We hereby appoint MDSS GmbH, Burckhardtatrasso 1, D.J0163 Hannover.


    Gormany to acl as Eu<opean Authorised RepresentaliYe as defined in Art. 1{j)
    This cerfüicate was filed unoer No. 2 � �32� MDSS on of 24
    MOSS has nolified the authortues. Thf:l abo'le named maoulacturer re<:eiv.es lhe
    Feb. 2o_n_4
    See
    ol tlle Medical De'lice Dire<:tive 93142/EEC.
    Cerb �ic.oJ:,a �·-��g��ticn
    S
    '•w�
    (l
    d lh s d ay C.1 � of JA...)
    :
    20 _Q{ al Utica. NY USA
    Reg No:

    �
    lra D. Dussler.Jr
    Managemenl Represenlalwe
    The necessary pre-r�uisites /01 plecing the ( E mark o" the abo�tfft{OOittfei:l'products ano
    rnarl<etir,g th.em in all Member States of \he Eurwein Union. have tl)_us beeo·luifl,)leo.

    :l. 4 of r--e'o, zo_QY.


    E. n c,Jio,dt5t7. 1
    D-30 lt?. H::r,o,.-.;r -
    R '�'''" .Lo�l-',! i-t�
    ,;tt!(ft,
    SigneO this day

    P1f'� 92�\.L
    R"'·G.?�

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