CERTIFICATO CE DEL SISTEMA DI GARANZIA DELLA QUALITÀ EC Quality Assurance System Certificate Si certifica che, sulla base dei risultati degli audit effettuati, il Sistema completo di garanzia di Qualità dell Azienda: We certify that, on the basis of audit carried out, the full Quality Assurance System of the Company: Indirizzo/Address: Via degli Abeti, 88/1 Pesaro Italia È conforme ai requisiti applicabili della / Is in compliance with the applicable requirements of: Direttiva 93/42/CEE, Allegato II escluso il pto 4, attuata in Italia con Dlgs. 46 del 1997/02/24 93/42/EEC Directive, Annex II without point 4, transposed in Italy by Dlgs. 46 of 1997/02/24 per le seguenti tipologie di Dispositivi Medici / for the following Medical Devices: Therapeutical lasers and probes Equipment for ionophoresis and electrostimulation Equipment for ultrasounds therapy Equipment for magnetic therapy Equipment for microwaves therapy Equipment for pressure therapy Combined electro and ultrasound therapy devices Combined electro, ultrasound, magnetic and laser therapy devices Vacuum therapy devices Identificazione/Identification: Vedere allegato tecnico al presente Certificato/See technical sheet enclosed to this certificate Il presente Certificato è soggetto al rispetto del regolamento CERMET ed è valido solo per le tipologie di dispositivi sopra identificate soggette a sorveglianza. L allegato tecnico è parte integrante del presente Certificato. This Certificate is subject to CERMET regulations and it is valid only for the above mentioned Medical Devices that are subject to survey. The technical sheet is an integrating part of this Certificate Data di emissione/issue date: 2006/12/28 Data ultima modifica/last revised date: 2009/10/19 Data scadenza/ Expiry date: 2011/12/28 Pagina/Page: 1di /of 10 Direttore Commerciale e Operativo Sales and Operations Manager Giampiero Belcredi Direttore Generale General Manager Rodolfo Trippodo
Laser terapeutici e manipoli / Therapeutical lasers and probes Lasermed 2100, Lasermed 2200 PR999 150 mw, PR999 500 mw, PR999 1100 mw, PR999 2000 mw, PR999 4000 mw, PR999 6000 mw PR999 8000 mw, LIS 1050 Laser 2000 Fisiolaser IRD, Fisiolaser IRD 2 Powerlight Butterfly, Powerlight Swing 150 mw, Powerlight Swing 500 mw, Powerlight Swing 2000 mw, Powerlight Swing 4000 mw, Powerlight Swing 6000 mw Lasertherapy doc 2 Medilaser, Medilaser Scan 100 mw, Medilaser Scan 800 mw, Medilaser Scan 1700 mw, Medilaser Scan 3500 mw, Medilaser Scan 7000 mw Pagina/Page: 2di /of 10
Laser terapeutici e manipoli / Therapeutical lasers and probes ENRAF NONIUS Endolaser SIXTUS ITALIA Sham Laser Apparecchiature per ionoforesi ed elettrostimolazione / Equipment for ionophoresis and electrostimulation Therapic 9400, Therapic 9200, Therapic 8400, Therapic 8200, Therapic 7400, Therapic 7200 Therapic 1500, Therapic 2000 Fisioter 2000, Fisioter 3000 Medicstim 4 complet, Medicstim 2 complet, Medicstim 2 MF, Medicstim 2 BF, Medicstim Basic Electro Butterfly, Electro Butterfly MF, Electro Butterfly LF Pagina/Page: 3di /of 10
Apparecchiature per ionoforesi ed elettrostimolazione / Equipment for ionophoresis and electrostimulation Electro doc 3, Electro doc 2 Electromed 4 LMF, Electromed 2 LMF, Electromed 2 MF, Electromed 4 LF, Electromed 2 LF DS MEDICA Linfodith SIXTUS ITALIA Sham E.T., Sham E.T. Plus Apparecchiature per ultrasuonoterapia / Equipment for ultrasounds therapy Ultrasonic 1500, Ultrasonic 1300, Ultrasonic 1100, Ultrasonic 2500, Ultrasonic 2200, Ultrasonic 2100 US 50, Ultracav 1100, Ultracav 2100 Elbasonic 2000, Elbasonic 3000, Elbasonic 4000 Pagina/Page: 4di /of 10
Apparecchiature per ultrasuonoterapia / Equipment for ultrasounds therapy Sonic 1 MHz, Sonic 1/3 MHz, Sonic 2 complet, Sonic 2 complet Trolley, Sonic Basic Sono Butterfly, Sono Butterfly 1 MHz, Sonocar Butterfly Ultrasuoni doc 1, Ultrasuoni doc 2 Medison 2 1/3, Medison 1/3, Medison car 1/3, Medison car 2 1/3 SIXTUS ITALIA Sham US, Sham US Plus Pagina/Page: 5di /of 10
Apparecchiature per magnetoterapia / Equipment for magnetic therapy Magnetomed 8400, Magnetomed 8200, Magnetomed 8100,Magnetomed 7400, Magnetomed 7200, Magnetomed 7100, Magnetomed 2000 Magnetoterapia 4000 Magnetobed 2, Magnetobed 4 Magnetocar butterfly, Magneto butterfly Magneto doc 3, Magneto doc 2 Magnetoplus 4, Magnetoplus 2, Magnetoplus 1 PHYSIOMED ELEKTROMEDIZIN AG Mag Expert Pagina/Page: 6di /of 10
Apparecchiature per radarterapia / Equipment for microwaves therapy Radarmed 2500 CP, Radarmed 2500 C, RT 250 Digital Radarterapia 2000 CP, Radarterapia 2000 C Microradar, Microradar PULS Thermo butterfly Radar doc Radar 250 CP, Radar 250 C Pagina/Page: 7di /of 10
Apparecchiature per pressoterapia / Equipment for pressure therapy Pressomed 2900, Pressomed 2700, Pressomed 707 KP, Endopress Artipress Medipress 9, Medipress 7 DS MEDICA Pressodith Doc press Butterfly Drain Pagina/Page: 8di /of 10
Dispositivi per terapia combinata elettrostimolazione ed ultrasuoni / Combined electro and ultrasound therapy devices Combimed 2100, Combimed 2200, Combimed 200 Combi 2500 Komby Combi butterfly Medicomb DS MEDICA Adipoclasth Pagina/Page: 9di /of 10
Dispositivi per terapia combinata elettrostimolazione, ultrasuoni, magneto e laser / Combined electro, ultrasound, magnetic and laser therapy devices Polyter 6, Polyter 10 SIXTUS ITALIA Sham Multifunzione 08 Dispositivi per vacuum terapia / Vacuum therapy devices Vacuumed Vacuum Pagina/Page: 10 di /of 10