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Ultrasonic Scaler Handpiece - EUDAMED Registration 06971560450373

Access comprehensive regulatory information for Ultrasonic Scaler Handpiece in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 06971560450373 and manufactured by Guilin Refine Medical Instrument Co.,Ltd. in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (DE/CA22 - Bezirksregierung Mรผnster), 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 IIa
06971560450373
Yes
Ultrasonic Scaler Handpiece
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

DENTAL CLEANING/WASHING HANDPIECE EQUIPMENTS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z12119006
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06971560450373
Basic UDI
B-06971560450373
Version Date
December 12, 2024
Manufacturer Last Update
June 12, 2024
Active Status
Yes
Manufacturer
Country
China
Country Type
NON_EU
Address
No.8-3 Information Industrial Park, High-Tech Zone, Qixing District Guilin,Guangxi
Email
refine@refine-med.com
Authorized Representative
SRN
DE-AR-000011194
Country
Germany
Address
10 Borkstrasse Mรผnster
Email
contact@mednet-ecrep.com
Regulatory Information
Competent Authority
DE/CA22 - Bezirksregierung Mรผnster
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Germany
Market Available
France:None~None, Germany:None~None, Greece:None~None, Italy:None~None, Lithuania:None~None, Romania:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No