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Paradise Catheter 7mm - EUDAMED Registration 00810008950036

Access comprehensive regulatory information for Paradise Catheter 7mm in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 00810008950036 and manufactured by ReCor Medical, Inc. in United States.

This page provides complete registration details including trade name (Paradiseโ„ข), 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 IIb
00810008950036
Yes
Paradise Catheter 7mm
Trade Name: Paradiseโ„ข
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Device Description (EMDN)

COMBINED RADIOFREQUENCY / ULTRASONIC SURGERY HANDPIECES, SINGLE-USE

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
K02050109
Trade Name
Paradiseโ„ข
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00810008950036
Basic UDI
B-00810008950036
Version Date
April 23, 2024
Manufacturer Last Update
August 10, 2023
Active Status
Yes
Manufacturer
Manufacturer Name
ReCor Medical, Inc.
Country
United States
Country Type
NON_EU
Address
1049 Elwell Court Palo Alto
Email
info@recormedical.com
Authorized Representative
SRN
IE-AR-000006507
Country
Ireland
Address
South County Business Park Leopardstown, Dublin 18
Email
IconAR@iconplc.com
Telephone
+ 353 (1) 291 2000
Regulatory Information
Competent Authority
Health Products Regulatory Authority, Medical Devices Department
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Germany
Market Available
Austria:None~None, Belgium:None~None, Czechia:None~None, France:None~None, Germany:None~None, Ireland:None~None, Italy:None~None, Netherlands:None~None, Poland:None~None, Spain:None~None, Greece:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No