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EUDAMED registration 89611030806462No

Dental Root Elevator

Medicure Instruments Class IEU EUDAMEDTrade name: Dental Root Elevator, Bein 2mm
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
L1505
Trade name
Dental Root Elevator, Bein 2mm
Implantable
No
Reusable
Yes
Measuring function
No
Registration information
Primary DI
89611030806462
Basic UDI
896110308DentalElevator3Y
Version date
December 11, 2022
Manufacturer last update
September 10, 2022
Active status
No
Manufacturer
Manufacturer name
Medicure Instruments
Country
Pakistan
Country type
NON_EU
Address
Sardar Pura, Muzaffar Pur, Sialkot, Punjab 51310 Pakistan Sialkot
Email
info@medicure.pk
Authorized representative
Name
TSI Quality Services
SRN
DK-AR-000017664
Country
Denmark
Address
52 2 th Blokland Albertslund
Email
info@techstandi.com
Telephone
08000016832
Regulatory information
Competent authority
Danish Medicines Agency, Pharmacovigilance & Medical Devices
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Denmark
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, Turkey:None~None, United Kingdom (Northern Ireland only):None~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

ODONTOSTOMATOLOGY LEVERS, REUSABLE

About this record

Access comprehensive regulatory information for Dental Root Elevator in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 89611030806462 and manufactured by Medicure Instruments in Pakistan.

This page provides complete registration details including trade name (Dental Root Elevator, Bein 2mm), manufacturer information, authorized representative details, competent authority (Danish Medicines Agency, Pharmacovigilance & Medical Devices), 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.