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PLAID Bandage(Dressing) - EUDAMED Registration 08805178004254

Access comprehensive regulatory information for PLAID Bandage(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 08805178004254 and manufactured by Young Chemical Co., Ltd. in Republic of Korea.

This page provides complete registration details including trade name (PLAID ADFLEX P.U. Transparent Dressing), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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
08805178004254
No
PLAID Bandage(Dressing)
Trade Name: PLAID ADFLEX P.U. Transparent Dressing
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Device Description (EMDN)

POLYURETHANE (OR OTHER MATERIAL) ADHESIVE DRESSINGS, WITH ABSORBENT PAD

Device Classification
Risk Class
Class I
CND Nomenclatures Code
M04010102
Trade Name
PLAID ADFLEX P.U. Transparent Dressing
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08805178004254
Basic UDI
8805178001AW
Version Date
April 11, 2024
Manufacturer Last Update
April 20, 2022
Active Status
No
Manufacturer
Manufacturer Name
Young Chemical Co., Ltd.
Country
Republic of Korea
Country Type
NON_EU
Address
80-93 Golden root-ro Gimhae-si, Gyeongsangnam-do
Email
hsyoun@youngchemical.co.kr
Authorized Representative
SRN
NL-AR-000024028
Country
Netherlands
Address
33 Prinses Margrietplantsoen The Hague
Email
EU-AR@medenvoyglobal.com
Telephone
+31 70 326 21 48
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Device Characteristics
Human Tissues
No
Animal Tissues
No