Pure Global

Catheter Sheath Introducer - RAIN Sheath™ Transradial Introducer - Polymer Mini Guidewire - EUDAMED Registration 10705032082082

Access comprehensive regulatory information for Catheter Sheath Introducer - RAIN Sheath™ Transradial Introducer - Polymer Mini Guidewire in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 10705032082082 and manufactured by Cordis US Corporation in United States.

This page provides complete registration details including trade name (RAIN Sheath™ Transradial Introducer), 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.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class IIa
10705032082082
No
Catheter Sheath Introducer - RAIN Sheath™ Transradial Introducer - Polymer Mini Guidewire
Trade Name: RAIN Sheath™ Transradial Introducer
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

CARDIOVASCULAR INTRODUCER SHEATHS, VALVED

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
C0502
Trade Name
RAIN Sheath™ Transradial Introducer
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
10705032082082
Basic UDI
07050320000000000000068D3
Version Date
October 06, 2023
Manufacturer Last Update
February 08, 2022
Active Status
No
Manufacturer
Manufacturer Name
Cordis US Corporation
Country
United States
Country Type
NON_EU
Address
14201 North West 60th Avenue Miami Lakes
Email
lynda.marchand@cordis.com
Authorized Representative
SRN
IE-AR-000017793
Country
Ireland
Address
Cahir Road Cashel, Co. Tipperary
Email
gmb-cordis-cashel-qra@cordis.com
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
Netherlands
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, Turkey:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No