EUROPA - European Commission - Growth - Regulatory policy

Notification

Found : 17

Body (History):

IRCM ISTITUTO DI RICERCHE E COLLAUDI MASINI S.R.L.
Via Moscova 11
20017 RHO
Country : Italy

Phone : +39:02:9301517
Fax : +39:02:9308176

Email : -
Website : -

Notified Body number : 0068

Version(s): 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

Last approval date : Unknown (Notifications pre-dating 2006 are not available in these lists)

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Some information about the accreditation details are available in the PDF

Legislation

93/42/EEC Medical devices (History)
Last approval date :

Products	Procedures	Articles/Annexes	Limitations
Dental instruments (non sterile) equipment	Full quality assurance system EC type-examination EC verification Production quality assurance Product quality assurance	Annex II Annex III Annex IV Annex V Annex VI
Equipment for aerosol therapy, humidification and nebulisation	Full quality assurance system EC type-examination EC verification Production quality assurance Product quality assurance	Annex II Annex III Annex IV Annex V Annex VI
Equipment for anaesthesia, assisted ventilation and support of vital functions
- surgical equipment and ancillary surgical equipment	Full quality assurance system EC type-examination EC verification Production quality assurance Product quality assurance	Annex II Annex III Annex IV Annex V Annex VI
Equipment for electrosurgery	Full quality assurance system EC type-examination EC verification Production quality assurance Product quality assurance	Annex II Annex III Annex IV Annex V Annex VI
Equipment for infusion, transfusion, extracorporeal circulation, plasmapheresis and blood collection	Full quality assurance system EC type-examination EC verification Production quality assurance Product quality assurance	Annex II Annex III Annex IV Annex V Annex VI
Equipment for measuring and/or monitoring and/or recording and/or analysing physiological parameters and vital functions	Full quality assurance system EC type-examination EC verification Production quality assurance Product quality assurance	Annex II Annex III Annex IV Annex V Annex VI
Equipment for nerve, heart or muscle stimulation or electrotherapy	Full quality assurance system EC type-examination EC verification Production quality assurance Product quality assurance	Annex II Annex III Annex IV Annex V Annex VI
Equipment for peritoneal dialysis and hemodialysis
- Equipment for endoscopy	Full quality assurance system EC type-examination EC verification Production quality assurance Product quality assurance	Annex II Annex III Annex IV Annex V Annex VI
Equipment for rehabilitation	Full quality assurance system EC type-examination EC verification Production quality assurance Product quality assurance	Annex II Annex III Annex IV Annex V Annex VI
Equipment for the production, visualisation and processing of images using non-ionising radiation or ultrasound	Full quality assurance system EC type-examination EC verification Production quality assurance Product quality assurance	Annex II Annex III Annex IV Annex V Annex VI
Equipment for treatment using non-ionising radiation or ultrasound	Full quality assurance system EC type-examination EC verification Production quality assurance Product quality assurance	Annex II Annex III Annex IV Annex V Annex VI
Incubators and equipment for neonatal pathology	Full quality assurance system EC type-examination EC verification Production quality assurance Product quality assurance	Annex II Annex III Annex IV Annex V Annex VI
Non-active devices for anaesthesia and assisted ventilation	Full quality assurance system EC type-examination EC verification Production quality assurance Product quality assurance	Annex II Annex III Annex IV Annex V Annex VI
Non-active devices for measuring physiological parameters	Full quality assurance system EC type-examination EC verification Production quality assurance Product quality assurance	Annex II Annex III Annex IV Annex V Annex VI
Non-active devices for surgery and endoscopy	Full quality assurance system EC type-examination EC verification Production quality assurance Product quality assurance	Annex II Annex III Annex IV Annex V Annex VI