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Negative Pressure Wound Therapy Dressing Kit - EUDAMED Registration 06938294453179

Access comprehensive regulatory information for Negative Pressure Wound Therapy Dressing Kit 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 06938294453179 and manufactured by Guangzhou Rainhome Pharm & Tech Co., Ltd in China.

This page provides complete registration details including trade name (welsuc), manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Dรผsseldorf 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 IIb
06938294453179
No
Negative Pressure Wound Therapy Dressing Kit
Trade Name: welsuc
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Device Description (EMDN)

DRAINAGE SYSTEMS WITH RESERVOIR

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
A0601010102
Trade Name
welsuc
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06938294453179
Basic UDI
69382944PU000UE
Version Date
May 29, 2024
Manufacturer Last Update
May 26, 2023
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
No. 10 Yongsheng Road Guangzhou
Email
zg04@rhkj.com.cn
Authorized Representative
SRN
DE-AR-000005081
Country
Germany
Address
5 Kennedydamm Dรผsseldorf
Email
info@eunitor.de
Regulatory Information
Competent Authority
DE/CA20, Bezirksregierung Dรผsseldorf Dezernat 24
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Belgium:None~None, Bulgaria:None~None, France:None~None, Germany:None~None, Italy:None~None, Netherlands:None~None, Poland:None~None, Tรผrkiye:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No