European Commission - Enterprise and Industry

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Notification

Found : 10
 
  Body :

INSTYTUT TECHNOLOGII ELEKTRONOWEJ ODDZIAƁ PREDOM
ul. Krakowiakow 53
02-255 WARSZAWA
Country : Poland

Phone : +48 22 846 54 31
Fax : +48 22 846 19 05

Email : obr@predom.com.pl
Website : www.predom.com.pl

Notified Body number : 1451

Version(s): 1 2 3 4 5 6 7

Last update : 03/12/2012
 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices     (History)
Last update : 16/12/2012                 Version(s): 1 2 3 4

Products Procedures Articles/Annexes Limitations
*MD 1100 - General active medical devices
 
   - *MD 1102 - Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
EC verification
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex IV
Annex V
Annex VI
only therapy inhalators except class II b, class III, sterile  
   - *MD 1103 - Devices for stimulation or inhibition
EC verification
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex IV
Annex V
Annex VI
only devices for stimulation except class II b, class III, sterile  
   - *MD 1104 - Active surgical devices
EC verification
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex IV
Annex V
Annex VI
except class II b, class III, sterile  
   - *MD 1108 - Active rehabilitation devices and active prostheses
EC verification
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex IV
Annex V
Annex VI
except class II b, class III, sterile active prosthesis 
*MD 1300 - Monitoring devices
 
   - *MD 1301 - Monitoring devices of non-vital physiological parameters
EC verification
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex IV
Annex V
Annex VI
except class II b, class III, sterile 
*MD 1400 - Devices for radiation therapy and thermo therapy
 
   - *MD 1402 - Devices utilising non-ionizing radiation
EC verification
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex IV
Annex V
Annex VI
except class II b, class III, sterile active prosthesis 
   - *MD 1403 - Devices for hyperthermia / hypothermia
EC verification
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex IV
Annex V
Annex VI
except class II b, class III, sterile 
 
Horizontal technical competence Limitations
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery