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Sterile Bandage - EUDAMED Registration 06971519612142

Access comprehensive regulatory information for Sterile Bandage 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 06971519612142 and manufactured by Anji Hengfeng Sanitary Material Co., Ltd in China.

This page provides complete registration details including trade name (EMSRUN), manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Düsseldorf Dezernat 24), 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
06971519612142
No
Sterile Bandage
Trade Name: EMSRUN
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Device Description (EMDN)

ELASTIC FIXING BANDAGES, NON-ADHESIVE, EXTENSIBLE IN ONE DIRECTION

Device Classification
Risk Class
Class I
CND Nomenclatures Code
M0303010101
Trade Name
EMSRUN
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06971519612142
Basic UDI
697151961HFEB01EU
Version Date
December 12, 2024
Manufacturer Last Update
September 13, 2021
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
/ Ancheng, Dipu Town 313300 Anji County Zhejiang P.R China. Anji County Zhejiang
Email
marketing@hfbandage.com
Authorized Representative
SRN
DE-AR-000005946
Country
Germany
Address
71 Niederrheinstraße Düsseldorf
Email
info@caretechion.de
Telephone
+49 211 2398900
Regulatory Information
Competent Authority
DE/CA20, Bezirksregierung Düsseldorf Dezernat 24
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Device Characteristics
Human Tissues
No
Animal Tissues
No