Pure Global

Silicone Boyle Davis Gag Cover (Non Sterile) - EUDAMED Registration 05060465560568

Access comprehensive regulatory information for Silicone Boyle Davis Gag Cover (Non Sterile) 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 05060465560568 and manufactured by Medasil Surgical Limited in United Kingdom (ex Northern Ireland).

This page provides complete registration details including 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
05060465560568
No
Silicone Boyle Davis Gag Cover (Non Sterile)
EU EUDAMED Registered Medical Device
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

COVERS, INSTRUMENTS AND EQUIPMENT - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
T030199
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05060465560568
Basic UDI
506046556140-10B9
Version Date
July 27, 2023
Manufacturer Last Update
July 12, 2021
Active Status
No
Manufacturer
Manufacturer Name
Medasil Surgical Limited
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
Medasil House, Hunslet Road Leeds
Email
quality@medasil.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
Ireland
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