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Sterile Dental Impression Copings - EUDAMED Registration 00844868017684

Access comprehensive regulatory information for Sterile Dental Impression Copings 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 00844868017684 and manufactured by Biomet 3i, LLC in United States.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (Agencia Española de Medicamentos y Productos Sanitarios), 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
00844868017684
No
Sterile Dental Impression Copings
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

DENTAL INSTRUMENTS, SINGLE-USE - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Q010599
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00844868017684
Basic UDI
844868A6H4
Version Date
August 05, 2024
Manufacturer Last Update
October 04, 2023
Active Status
No
Manufacturer
Manufacturer Name
Biomet 3i, LLC
Country
United States
Country Type
NON_EU
Address
4555 Riverside Drive Palm Beach Gardens
Email
DentalCS@zimvie.com
Authorized Representative
SRN
ES-AR-000000983
Country
Spain
Address
40 C/ Tirso de Molina Cornellá de Llobregat, Barcelona
Email
ruth.lopez@zimvie.com
Telephone
+34 661 240 438
Regulatory Information
Competent Authority
Agencia Española de Medicamentos y Productos Sanitarios
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Spain
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, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No