European Commission - Growth

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Notification
Found : 41
 
  Body :

CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.
Erdő u.101.
Budakeszi
Country : Hungary

Phone : 00-36-23-880-830
Fax : 00-36-23-880-831

Email : info@cecertiso.hu
Website : www.cecertiso.hu

Notified Body number : 2409

Version(s): 1 2

Last approval date : 20/02/2020
 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices    
Last approval date : 08/09/2020                 Version(s): 1 2 3 4 5 6

Products Procedures Articles/Annexes Limitations
*MD 0100 - General non-active, non-implantable medical devices
  
   - *MD 0101 - Non-active devices for anaesthesia, emergency and intensive care
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
   - *MD 0102 - Non-active devices for injection, infusion, transfusion and dialysis
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
   - *MD 0103 - Non-active orthopaedic and rehabilitation devices
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
   - *MD 0104 - Non-active medical devices with measuring function
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
   - *MD 0105 - Non-active ophthalmologic devices
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
   - *MD 0106 - Non-active instruments
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
   - *MD 0107 - Contraceptive medical devices
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
   - *MD 0108 - Non-active medical devices for disinfecting, cleaning, rinsing
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
   - *MD 0109 - Non-active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART)
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
   - *MD 0110 - Non-active medical devices for ingestion
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
*MD 0200 - Non-active implants
  
   - *MD 0201 - Non-active cardiovascular implants
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
   - *MD 0202 - Non-active orthopaedic implants
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
   - *MD 0203 - Non-active functional implants
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
   - *MD 0204 - Non-active soft tissue implants
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
*MD 0300 - Devices for wound care
  
   - *MD 0301 - Bandages and wound dressings
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
   - *MD 0302 - Suture material and clamps
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
   - *MD 0303 - Other medical devices for wound care
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
*MD 0400 - Non-active dental devices and accessories
  
   - *MD 0401 - Non-active dental equipment and instruments
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
   - *MD 0402 - Dental materials
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
   - *MD 0403 - Dental implants
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
*MD 1100 - General active medical devices
  
   - *MD 1101 - Devices for extra-corporal circulation, infusion and haemopheresis
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
   - *MD 1102 - Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
   - *MD 1103 - Devices for stimulation or inhibition
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
   - *MD 1104 - Active surgical devices
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
   - *MD 1105 - Active ophthalmologic devices
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
   - *MD 1106 - Active dental devices
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
   - *MD 1107 - Active devices for disinfection and sterilisation
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
   - *MD 1108 - Active rehabilitation devices and active prostheses
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
   - *MD 1111 - Software
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
*MD 1200 - Devices for imaging
  
   - *MD 1202 - Imaging devices utilising non-ionizing radiation
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
*MD 1300 - Monitoring devices
  
   - *MD 1301 - Monitoring devices of non-vital physiological parameters
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
   - *MD 1302 - Monitoring devices of vital physiological parameters
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
*MD 1400 - Devices for radiation therapy and thermo therapy
  
   - *MD 1402 - Devices utilising non-ionizing radiation
 EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)		 Annex II
Annex V
Annex VI		  
 
Horizontal technical competence Limitations
*MDS 7001 - Medical devices incorporating medicinal substances, according to Directive 2001/83/EC regarding Annex II, V, VI
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery regarding Annex II, V, VI
*MDS 7006 - Medical devices in sterile condition regarding Annex II, V, VI Including aseptic processing, ethylene oxide gas sterilisation (EOG), radiation sterilization (gamma,x-ray, electron beam), moist heat sterilization
*MDS 7009 - Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbed regarding Annex II, V, VI
*MDS 7010 - Medical devices incorporating software /utilising software /controlled by software regarding Annex II, V, VI