The NANDO database has a new Notified Body under the MDR!
Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi is the 40th EU Notified Body notified under the Regulation (EU) 2017/745 on medical devices – MDR.
Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi
Esentepe Mahallesi Milangaz Caddesi No:75 A/92 Kartal/İstanbul
Istanbul Türkiye
Body Number: 2764
Email: info@notice.com.tr
The Notification covers the following:
General non-active, non-implantable medical devices
- MD 0101 – Non-active devices for anaesthesia, emergency and intensive care
- MD 0102 – Non-active devices for injection, infusion, transfusion and dialysis
- MD 0104 – Non-active medical devices with measuring function
- MD 0105 – Non-active ophthalmologic devices
- MD 0108 – Non-active medical devices for disinfecting, cleaning, rinsing
Non-active implants
- MD 0201 – Non-active cardiovascular implants
- MD 0202 – Non-active orthopaedic implants
- MD 0203 – Non-active functional implants
- MD 0204 – Non-active soft tissue implants
Devices for wound care
- MD 0301 – Bandages and wound dressings
- MD 0302 – Suture material and clamps
- MD 0303 – Other medical devices for wound car
Non-active dental devices and accessories
- MD 0401 – Non-active dental equipment and instruments
- MD 0402 – Dental materials
- MD 0403 – Dental implants
General active medical devices
- MD 1101 – Devices for extra-corporal circulation, infusion and haemopheresis
- MD 1102 – Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
- MD 1104 – Active surgical devices
- MD 1111 – Software
Monitoring devices
- MD 1301 – Monitoring devices of non-vital physiological parameters
- MD 1302 – Monitoring devices of vital physiological parameters
Devices for radiation therapy and thermo therapy
- MD 1402 – Devices utilising non-ionizing radiation
Horizontal technical competence
- MDS 7001 – Medical devices incorporating medicinal substances, according to Directive 2001/83/EC
- MDS 7004 – Medical devices referencing the Directive 2006/42/EC on machinery
- MDS 7006 – Medical devices in sterile condition
- Limitations including aseptic, processing, ethylene oxide gas, sterilisation (EOG), moist heat sterilisation, radiation sterilisation (gamma, x-ray, electron beam)
- MDS 7009 – Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbed
- MDS 7010 – Medical devices incorporating software/utilising software/controlled by software
You can find the full scope of its designation on the following link.
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