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Mathieu Ultra Fine Tip - EUDAMED Registration 08964003881849

Access comprehensive regulatory information for Mathieu Ultra Fine Tip 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 08964003881849 and manufactured by Lead Dental Instruments Co. in Pakistan.

This page provides complete registration details including trade name (Tiger), 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
08964003881849
No
Mathieu Ultra Fine Tip
Trade Name: Tiger
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Device Description (EMDN)

MICROSURGERY NEEDLE HOLDERS, REUSABLE

Device Classification
Risk Class
Class I
CND Nomenclatures Code
L1004
Trade Name
Tiger
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
08964003881849
Basic UDI
8964004046300-20-020DKB
Version Date
July 10, 2024
Manufacturer Last Update
October 25, 2022
Active Status
No
Manufacturer
Country
Pakistan
Country Type
NON_EU
Address
Village Rahim pur, PO Ugoki, Wazirabad Road Sialkot
Email
sales@leadorthodent.com
Authorized Representative
SRN
HU-AR-000034102
Country
Hungary
Address
13. al. 1 Budapest, Aurรณra utca BUDAPEST
Email
eudamed.representative@gmail.com
Telephone
+36706790786
Regulatory Information
Competent Authority
Danish Medicines Agency, Pharmacovigilance & Medical Devices
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Belgium:None~None, Denmark:None~None, France:None~None, Germany:None~None, Italy:None~None, Norway:None~None, Poland:None~None, Portugal: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