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Cross linked 2 - EUDAMED Registration +EPOLCLI7C10O

Access comprehensive regulatory information for Cross linked 2 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 +EPOLCLI7C10O and manufactured by Polident d.o.o. Industrija dentalnih proizvodov in Slovenia.

This page provides complete registration details including trade name (Cross linked 2 ), 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
+EPOLCLI7C10O
No
Cross linked 2
Trade Name: Cross linked 2
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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
Cross linked 2
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
+EPOLCLI7C10O
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