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Vacuum Fixation Mouthpiece, Small (10 pack) - EUDAMED Registration +B365505000

Access comprehensive regulatory information for Vacuum Fixation Mouthpiece, Small (10 pack) 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 +B365505000 and manufactured by Aktina Medical Corp in United States.

This page provides complete registration details including trade name (PInPoint System), manufacturer information, authorized representative details, competent authority (Health Products Regulatory Authority, Medical Devices Department), 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
+B365505000
Yes
Vacuum Fixation Mouthpiece, Small (10 pack)
Trade Name: PInPoint System
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Device Description (EMDN)

LINEAR ACCELERATORS – OTHER

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z11010199
Trade Name
PInPoint System
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
+B365505000
Basic UDI
++B365505XXPinPointSys6J
Version Date
October 07, 2023
Manufacturer Last Update
May 28, 2021
Active Status
Yes
Manufacturer
Manufacturer Name
Aktina Medical Corp
Country
United States
Country Type
NON_EU
Address
360 Aktina Medical Corp. 10920-1420 Congers. New York
Email
tony@aktina.com
Authorized Representative
SRN
IE-AR-000003999
Country
Ireland
Address
Stratton House, BISHOPSTOWN ROAD CORK
Email
tqmuk@aol.com
Telephone
+447545595464
Regulatory Information
Competent Authority
Health Products Regulatory Authority, Medical Devices Department
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Austria
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