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EUDAMED registration 00840326423790No

Compule Gun Light Grey Unodent

Astek Innovations LtdClass IEU EUDAMEDTrade name: Compule Gun Blue Unodent
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
Q010199
Trade name
Compule Gun Blue Unodent
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
00840326423790
Basic UDI
50601117835696FP
Version date
February 21, 2025
Manufacturer last update
September 17, 2021
Active status
No
Manufacturer
Manufacturer name
Astek Innovations Ltd
Country
United Kingdom (ex Northern Ireland)
Country type
NON_EU
Address
Astek House Atlantic Street Altrincham
Email
info@astekinnovations.co.uk
Authorized representative
Name
Young Microbrush Ireland Ltd
SRN
IE-AR-000011249
Country
Ireland
Address
Clogherane Dungarven, County Waterford
Email
YMBI@younginnovations.com
Telephone
+ 35 3 584 59 66
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
Germany
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER

About this record

Access comprehensive regulatory information for Compule Gun Light Grey Unodent 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 00840326423790 and manufactured by Astek Innovations Ltd in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (Compule Gun Blue Unodent), 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.