Eu Mdr Eu Md Class 1 On The Market

SmartPDT-P iOS

Devices (same UDI-DI)
3
Certificates
0
Countries
28
Notified Bodies
0

Basic Information

Primary DI
05060861070012
Basic UDI-DI Code
506086107SIHSDTCV
Reference
SmartPDT-P iOS
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market
Manufacturer
siHealth Ltd.

Additional Description

The SmartPDT®-P app is the patient interface of SmartPDT®, siHealth’s digital solution for Photodynamic Therapy (PDT). SmartPDT® is a CE marked software medical device class I, compliant to the European Medical Device Regulation 2017/745 and fully compliant to data protection regulations (e.g. GDPR). It’s based on the siHealth’s patented technology for the sensor-less monitoring of solar radiation, anywhere and anytime (https://www.happysun.co.uk). SmartPDT® enables the use of daylight Photodynamic Therapy (dPDT), the natural alternative method to conventional laser or lamp photodynamic therapy, in a safe and reliable way from remote. The SmartPDT®-P app can be used only by patients that received access credentials generated on the SmartPDT®-D web-portal by their healthcare providers. More information for activating a SmartPDT® account can be found at https://www.smartpdt.com or by contacting us at [email protected].

CND Nomenclature Codes

Code Description
Z12040292 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Available In Countries

🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇾 Cyprus 🇨🇿 Czechia 🇩🇪 Germany 🇩🇰 Denmark 🇪🇪 Estonia 🇬🇷 Greece 🇪🇸 Spain 🇫🇮 Finland 🇫🇷 France 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇹 Italy 🇱🇹 Lithuania 🇱🇺 Luxembourg 🇱🇻 Latvia 🇲🇹 Malta 🇳🇱 Netherlands 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇪 Sweden 🇸🇮 Slovenia 🇸🇰 Slovakia 🇬🇧 United Kingdom

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