Pure Global

Genedrive System - EUDAMED Registration 05060654860417

Access comprehensive regulatory information for Genedrive System in the European Union medical device market through Pure Global AI's free database. This Class A device is registered with EU EUDAMED under Primary DI 05060654860417 and manufactured by Genedrive Diagnostics Ltd. in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (Genedrive System), 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.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class A
05060654860417
No
Genedrive System
Trade Name: Genedrive System
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W02050301
Trade Name
Genedrive System
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05060654860417
Basic UDI
506065486GS-002Y2
Active Status
No
Manufacturer
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
48 Grafton Street Manchester
Email
c.alexander@genedrive.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
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed On The Market
Malta
Device Characteristics
Human Tissues
No
Animal Tissues
No