Pure Global AI
EUDAMED registration 00817508013025No

DynamX Sirolimus Eluting Coronary Bioadaptor System

Elixir Medical CorporationClass IIIEU EUDAMEDTrade name: DynamX Sirolimus Eluting Coronary Bioadaptor System
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class III
CND nomenclatures code
P070402010301
Trade name
DynamX Sirolimus Eluting Coronary Bioadaptor System
Implantable
Yes
Reusable
No
Measuring function
No
Registration information
Primary DI
00817508013025
Basic UDI
B-00817508013025
Version date
April 18, 2023
Manufacturer last update
September 13, 2021
Active status
No
Manufacturer
Manufacturer name
Elixir Medical Corporation
Country
United States
Country type
NON_EU
Address
920 N. McCarthy Blvd Milpitas
Email
info@elixirmedical.com
Authorized representative
Name
Acorn Regulatory Consultancy Services Ltd
SRN
IE-AR-000000592
Country
Ireland
Address
Knockmorris Co. Tipperary
Email
prrc@acornregulatory.com
Telephone
+ 353 52 6176706
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
Sweden
Market available
Belgium:None~None, Germany:None~None, Sweden:None~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS

About this record

Access comprehensive regulatory information for DynamX Sirolimus Eluting Coronary Bioadaptor System in the European Union medical device market through Pure Global AI's free database. This Class III device is registered with EU EUDAMED under Primary DI 00817508013025 and manufactured by Elixir Medical Corporation in United States.

This page provides complete registration details including trade name ( DynamX Sirolimus Eluting Coronary Bioadaptor System), 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.