Pure Global

Orthodontic Impression Tray - EUDAMED Registration 05060111782887

Access comprehensive regulatory information for Orthodontic Impression Tray 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 05060111782887 and manufactured by Astek Innovations Ltd in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (Bite Trays Sideless Posterior (50 pcs) - 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.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class I
05060111782887
No
Orthodontic Impression Tray
Trade Name: Bite Trays Sideless Posterior (50 pcs) - Unodent
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

IMPRESSION MATERIAL TRAYS, SINGLE-USE

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Q010503
Trade Name
Bite Trays Sideless Posterior (50 pcs) - Unodent
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05060111782887
Basic UDI
50601117816350117WA
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