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Silflex - EUDAMED Registration 05060031473865

Access comprehensive regulatory information for Silflex in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 05060031473865 and manufactured by Brightwake Limited in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (Silflex), 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 IIb
05060031473865
No
Silflex
Trade Name: Silflex
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Device Description (EMDN)

SILICONE DRESSINGS, NON-COMBINED

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
M04040701
Trade Name
Silflex
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05060031473865
Basic UDI
B-05060031473865
Version Date
February 26, 2025
Manufacturer Last Update
August 13, 2024
Active Status
No
Manufacturer
Manufacturer Name
Brightwake Limited
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
Lowmoor Business Park Kirkby in Ashfield
Email
ra@brightwake.co.uk
Authorized Representative
SRN
IE-AR-000004113
Country
Ireland
Address
The Black Church Dublin
Email
edwin@cslifesciences.com
Telephone
+447917134922
Regulatory Information
Competent Authority
Health Products Regulatory Authority, Medical Devices Department
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Ireland
Market Available
Croatia:None~None, Germany:None~None, Ireland:None~None, Portugal:None~None, Slovakia:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No