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EUDAMED registration 08806367064783No

Biliary Stent with Delivery System

M.I.Tech Co., LtdClass IIbEU EUDAMEDTrade name: HANAROSTENT®
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIb
CND nomenclatures code
P0502
Trade name
HANAROSTENT®
Implantable
Yes
Reusable
No
Measuring function
No
Registration information
Primary DI
08806367064783
Basic UDI
B-08806367064783
Version date
October 05, 2022
Manufacturer last update
March 20, 2023
Active status
No
Manufacturer
Manufacturer name
M.I.Tech Co., Ltd
Country
Republic of Korea
Country type
NON_EU
Address
174, Habuk 2-gil, Jinwi-myeon Pyeongtaek-si, Gyeonggi-do
Email
mitech@mitech.co.kr
Authorized representative
Name
KTR Europe GmbH
SRN
DE-AR-000005685
Country
Germany
Address
77 Mergenthalerallee Eschborn
Email
ktreurope@ktreurope.de
Telephone
+49 6196 887 170
Regulatory information
Competent authority
DE/CA29 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
Germany
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
Device description (EMDN)

BILIARY AND PANCREATIC PROSTHESES

About this record

Access comprehensive regulatory information for Biliary Stent with Delivery System 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 08806367064783 and manufactured by M.I.Tech Co., Ltd in Republic of Korea.

This page provides complete registration details including trade name (HANAROSTENT®), manufacturer information, authorized representative details, competent authority (DE/CA29 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt), 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.