Eu Mdd Eu Md Class 2a On The Market 🇧🇷 Brazil

Intraoral dental digital imaging sensor

Devices (same UDI-DI)
1
Certificates
1
Countries
32
Notified Bodies
1

Basic Information

Primary DI
07899581333972
Basic UDI-DI Code
B-07899581333972
Reference
16000002940
Device Types
None provided
Regulation
Eu Mdd
Classification
Eu Md Class 2a
Status
On The Market

Additional Description

The Intraoral dental digital imaging sensor uses a sensor that employs the associated technologies from CMOS (Complementary Metal-Oxide- emiconductor), protective optical fiber and scintillator and it was developed to obtain a high-quality x-ray image from the human arch and its structures. The acquisition process is made by positioning the sensor inside the mouth, behind the structure you want to perform the exam. The structure must be exposed to an x-ray dose using an external source. Once exposed, the sensor performs a conversion of the x-ray photons into a digital sign and transfers it to a computer through USB connection (Universal Serial Bus)

CND Nomenclature Codes

Code Description
Z11030402 SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY

Certificates

Type Number
MDD Annex II (excluding section 4) 286035-2019-CE-BRA-NA-PS

Available In Countries

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

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