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Hydrocolloid Dressing - EUDAMED Registration 08800048016641

Access comprehensive regulatory information for Hydrocolloid Dressing in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 08800048016641 and manufactured by T&L Co.,Ltd. in Republic of Korea.

This page provides complete registration details including trade name (Mighty Patch), 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.

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EUDAMED Official Data
Class I
08800048016641
No
Hydrocolloid Dressing
Trade Name: Mighty Patch
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Device Description (EMDN)

HYDROCOLLOID DRESSINGS, NON-COMBINED

Device Classification
Risk Class
Class I
CND Nomenclatures Code
M04040301
Trade Name
Mighty Patch
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08800048016641
Basic UDI
88000480TLDOCMDR150NP
Version Date
March 06, 2025
Manufacturer Last Update
November 16, 2021
Active Status
No
Manufacturer
Manufacturer Name
T&L Co.,Ltd.
Country
Republic of Korea
Country Type
NON_EU
Address
70-17 Won-gok-myeon, Wonam-ro Gyeonggi-do, Anseong-si
Email
ihjyhs00@naver.com
Authorized Representative
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
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Belgium:None~None, Czechia:None~None, Denmark:None~None, Finland:None~None, France:None~None, Germany:None~None, Italy:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Romania:None~None, Slovakia:None~None, Spain:None~None, Sweden:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No