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Restorative dental hand instrument - EUDAMED Registration 06438311707396

Access comprehensive regulatory information for Restorative dental hand instrument 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 06438311707396 and manufactured by LM-Instruments Oy in Finland.

This page provides complete registration details including trade name (LM Build-up Shaper DD DTS U), manufacturer information, competent authority (Finnish Medicines Agency, Supervision and licences, Medical Device Unit), 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
06438311707396
No
Restorative dental hand instrument
Trade Name: LM Build-up Shaper DD DTS U
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Device Description (EMDN)

DENTAL RESTORATION DEVICES - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Q01010199
Trade Name
LM Build-up Shaper DD DTS U
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06438311707396
Basic UDI
6438311RESTO102Y
Version Date
March 06, 2025
Manufacturer Last Update
November 03, 2021
Active Status
No
Manufacturer
Manufacturer Name
LM-Instruments Oy
Country
Finland
Country Type
EU_MEMBER_STATE
Address
8 Norrbyn rantatie Parainen
Email
info@lm-dental.com
Regulatory Information
Competent Authority
Finnish Medicines Agency, Supervision and licences, Medical Device Unit
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Finland
Market Available
Finland:None~None, Austria:None~None, Belgium:None~None, Bulgaria:None~None, Cyprus:None~None, Czechia:None~None, Germany:None~None, Denmark:None~None, Estonia:None~None, Spain:None~None, France:None~None, Greece:None~None, Croatia:None~None, Hungary:None~None, Ireland:None~None, Iceland:None~None, Italy:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Latvia:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Sweden:None~None, Slovenia:None~None, Slovakia:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No