Eu Mdr Eu Md Class 1 On The Market

SmartPDT-D

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

Basic Information

Primary DI
05060861070005
Basic UDI-DI Code
506086107SIHSDTCV
Reference
SmartPDT-D
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market
Manufacturer
siHealth Ltd.

Additional Description

SmartPDT® enables the use of daylight-PDT, the natural alternative method to conventional laser or lamp photodynamic therapy, in a safe and reliable way remotely within the patient’s own home. With its simple and effective smartphone-based application and web-portal dashboard interfaces, SmartPDT® has been designed for those who are both novice and well-trained in daylight-PDT. It provides doctors and healthcare staff with time-saving administrative solutions, actionable data, and accurate tracking of photosensitiser (Protoporphyrin IX or PpIX) while offering optimal comfort and convenience for patients. SmartPDT® is a CE marked software system, compliant to the European Medical Device Regulation 2017/745. SmartPDT®-D is the interface for the clinical staff of SmartPDT®, available online as web-portal.

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 🇮🇸 Iceland 🇮🇹 Italy 🇱🇹 Lithuania 🇱🇺 Luxembourg 🇱🇻 Latvia 🇲🇹 Malta 🇳🇱 Netherlands 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇪 Sweden 🇸🇮 Slovenia 🇸🇰 Slovakia 🇬🇧 United Kingdom

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