EUDAMED registration 05060111783105NoMouth Props - Assorted (Small, Medium and Large)
- Risk class
- Class I
- CND nomenclatures code
- Q010599
- Trade name
- Mouth Prop - Large Unodent
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 05060111783105
- Basic UDI
- 50601117842345ED
- Version date
- February 21, 2025
- Manufacturer last update
- September 17, 2021
- Active status
- No
- Manufacturer name
- Astek Innovations Ltd
- Country
- United Kingdom (ex Northern Ireland)
- Country type
- NON_EU
- Address
- Astek House Atlantic Street Altrincham
- info@astekinnovations.co.uk
- SRN
- IE-AR-000011249
- Country
- Ireland
- Address
- Clogherane Dungarven, County Waterford
- YMBI@younginnovations.com
- Telephone
- + 35 3 584 59 66
- Competent authority
- Health Products Regulatory Authority, Medical Devices Department
- Applicable legislation
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Placed on the market
- Germany
- Human tissues
- No
- Animal tissues
- No
DENTAL INSTRUMENTS, SINGLE-USE - OTHER
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 05060111783105 and manufactured by Astek Innovations Ltd in United Kingdom (ex Northern Ireland).
This page provides complete registration details including trade name (Mouth Prop - Large 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.