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Surgical Gowns - EUDAMED Registration 06974633370028

Access comprehensive regulatory information for Surgical Gowns 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 06974633370028 and manufactured by Sichuan Shuzhan New Materials Co., Ltd in China.

This page provides complete registration details including 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
06974633370028
No
Surgical Gowns
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

STANDARD SURGICAL GOWNS

Device Classification
Risk Class
Class I
CND Nomenclatures Code
T020401
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06974633370028
Basic UDI
697463337E-BQ3
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
18 West Section of Gangyuan Road Yibin
Email
373940134@qq.com
Authorized Representative
SRN
DE-AR-000005132
Country
Germany
Address
83 Heerdter Lohweg Düsseldorf
Email
eu-rep@share-info.com
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
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No