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RDi Sexual Health Collection Kits - EUDAMED Registration 05056751600537

Access comprehensive regulatory information for RDi Sexual Health Collection Kits 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 05056751600537 and manufactured by REAL Digital International Ltd in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (Sexual Health Collection Kit), 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.

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EUDAMED Official Data
Class A
05056751600537
No
RDi Sexual Health Collection Kits
Trade Name: Sexual Health Collection Kit
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Device Description (EMDN)

SAMPLES COLLECTION DEVICES - OTHER

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W05019099
Trade Name
Sexual Health Collection Kit
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05056751600537
Basic UDI
50567516MDTF0043P2
Version Date
September 20, 2024
Manufacturer Last Update
December 13, 2023
Active Status
No
Manufacturer
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
2 Queensway CR0 4BD Croydon
Email
JamesMears@real-digital.co.uk
Authorized Representative
SRN
NL-AR-000037688
Country
Netherlands
Address
2b Lange Viestraat Utrecht
Email
eurep@casusconsulting.com
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed On The Market
Ireland
Market Available
Ireland:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No