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Rubber Dam Frame - EUDAMED Registration 89611030869146

Access comprehensive regulatory information for Rubber Dam Frame 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 89611030869146 and manufactured by Medicure Instruments in Pakistan.

This page provides complete registration details including trade name (Rubber Dam Frame ), 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.

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EUDAMED Official Data
Class I
89611030869146
No
Rubber Dam Frame
Trade Name: Rubber Dam Frame
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Device Description (EMDN)

CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Q010199
Trade Name
Rubber Dam Frame
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
89611030869146
Basic UDI
896110308RubberDamFrameZL
Version Date
May 05, 2023
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
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