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Adhesive Plaster - EUDAMED Registration 05706636594108

Access comprehensive regulatory information for Adhesive Plaster 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 05706636594108 and manufactured by RFX+CARE Manufacturing Co., Ltd. in China.

This page provides complete registration details including trade name (Normal print textile plaster Leo ), manufacturer information, authorized representative details, competent authority (Danish Medicines Agency, Pharmacovigilance & Medical Devices), 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
05706636594108
No
Adhesive Plaster
Trade Name: Normal print textile plaster Leo
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Device Description (EMDN)

MEDICAL PLASTERS - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
M0599
Trade Name
Normal print textile plaster Leo
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05706636594108
Basic UDI
69228209MDN1204IN0000024L
Version Date
January 24, 2025
Manufacturer Last Update
August 16, 2024
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
No.599-1F Wuxie Road, Yuecheng District, Shaoxing, Zhejiang, China 312000 Shaoxing
Email
benjamin@rfx-care.com
Authorized Representative
SRN
DK-AR-000001768
Country
Denmark
Address
22B Gammel Strandvej Nivรฅ
Email
info@rfxcare.com
Telephone
+45 45769020
Regulatory Information
Competent Authority
Danish Medicines Agency, Pharmacovigilance & Medical Devices
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Denmark
Device Characteristics
Human Tissues
No
Animal Tissues
No