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Mouth Props - Assorted (Small, Medium and Large) - EUDAMED Registration 05060111783112

Access comprehensive regulatory information for Mouth Props - Assorted (Small, Medium and Large) 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 05060111783112 and manufactured by Astek Innovations Ltd in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (Mouth Prop - Assorted 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.

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EUDAMED Official Data
Class I
05060111783112
No
Mouth Props - Assorted (Small, Medium and Large)
Trade Name: Mouth Prop - Assorted Unodent
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Device Description (EMDN)

DENTAL INSTRUMENTS, SINGLE-USE - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Q010599
Trade Name
Mouth Prop - Assorted Unodent
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05060111783112
Basic UDI
50601117842345ED
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
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