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Materials for the preparation of custom-made dental devices - other - EUDAMED Registration +EPOLPRI46Y40S

Access comprehensive regulatory information for Materials for the preparation of custom-made dental devices - other in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI +EPOLPRI46Y40S and manufactured by Polident d.o.o. Industrija dentalnih proizvodov in Slovenia.

This page provides complete registration details including trade name (Primodent ), manufacturer information, competent authority (Javna agencija Republike Slovenije za zdravila in medicinske pripomoฤke.), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.

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EUDAMED Official Data
Class IIa
+EPOLPRI46Y40S
No
Materials for the preparation of custom-made dental devices - other
Trade Name: Primodent
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Device Description (EMDN)

MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Q010699
Trade Name
Primodent
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
+EPOLPRI46Y40S
Basic UDI
++EPOLAPTKB
Active Status
No
Manufacturer
Country
Slovenia
Country Type
EU_MEMBER_STATE
Address
42 Volcja Draga Volcja Draga
Email
polident@polident.si
Regulatory Information
Competent Authority
Javna agencija Republike Slovenije za zdravila in medicinske pripomoฤke.
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Slovenia
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Tรผrkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No