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Assistive Switches - EUDAMED Registration 05060895630947

Access comprehensive regulatory information for Assistive Switches 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 05060895630947 and manufactured by Pretorian Technologies Ltd in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (Leaf Switch), 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 I
05060895630947
Yes
Assistive Switches
Trade Name: Leaf Switch
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Device Description (EMDN)

DEVICES FOR INTERPERSONAL COMUNICATION - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Y214299
Trade Name
Leaf Switch
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05060895630947
Basic UDI
506089563SWS1H6
Version Date
September 10, 2024
Manufacturer Last Update
June 25, 2021
Active Status
Yes
Manufacturer
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
Unit 37 Corringham Road Industrial Estate DN21 1QB Gainsborough
Email
dave@pretorianuk.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, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No