Pure Global

Angiocontrol - Hand Controller - Accessory - EUDAMED Registration 35051223037522

Access comprehensive regulatory information for Angiocontrol - Hand Controller - Accessory 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 35051223037522 and manufactured by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (AngiOcOntrol), manufacturer information, authorized representative details, competent authority (Malta Medicines Authority), 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
35051223037522
No
Angiocontrol - Hand Controller - Accessory
Trade Name: AngiOcOntrol
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Device Description (EMDN)

INTERVENTIONAL CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
C0104010280
Trade Name
AngiOcOntrol
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
35051223037522
Basic UDI
5051223ANGIOCONTROLXC
Version Date
February 13, 2025
Manufacturer Last Update
June 28, 2024
Active Status
No
Manufacturer
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
2 Chestnut House Shenley
Email
glen.hillsley@purplesurgical.com
Authorized Representative
SRN
MT-AR-000000234
Country
Malta
Address
Tower Street Swatar
Email
prrc@advena.mt
Regulatory Information
Competent Authority
Malta Medicines Authority
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Spain
Market Available
Denmark:2025-02-14~None, France:2025-02-14~None, Germany:2025-02-14~None, Italy:2025-02-14~None, Spain:2025-02-14~None, Sweden:2025-02-14~None
Device Characteristics
Human Tissues
No
Animal Tissues
No