Pure Global

High-Definition Custom Silicone - EUDAMED Registration 50563496503714

Access comprehensive regulatory information for High-Definition Custom Silicone 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 50563496503714 and manufactured by Hugh Steeper Limited in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (Below elbow w limb build), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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
50563496503714
No
High-Definition Custom Silicone
Trade Name: Below elbow w limb build
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Y061809
Trade Name
Below elbow w limb build
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
50563496503714
Basic UDI
50553482ASCTU
Version Date
November 28, 2024
Manufacturer Last Update
July 20, 2021
Active Status
No
Manufacturer
Manufacturer Name
Hugh Steeper Limited
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
Unit 3, Stourton Link, LS10 1DF Leeds
Email
tony.coulson@steepergroup.com
Authorized Representative
SRN
NL-AR-000000116
Country
Netherlands
Address
60 Westervoortsedijk Arnhem
Email
lst.aus.euauthrep@ul.com
Telephone
+31 70 345 8570
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Netherlands
Device Characteristics
Human Tissues
No
Animal Tissues
No