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Accufuser Omnibus - EUDAMED Registration D-NSE040610XLNF

Access comprehensive regulatory information for Accufuser Omnibus 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 D-NSE040610XLNF and manufactured by Woo Young Medical Co., Ltd. in Republic of Korea.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten), 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
D-NSE040610XLNF
Yes
Accufuser Omnibus
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

ELASTOMERIC SYSTEMS - VARIABLE FLOW WITH ADDITIONAL BOLUS

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
A05010202
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
D-NSE040610XLNF
Basic UDI
B-NSE040610XLNF
Version Date
November 01, 2023
Manufacturer Last Update
June 14, 2022
Active Status
Yes
Manufacturer
Country
Republic of Korea
Country Type
NON_EU
Address
2 Sangsin-gil, Jincheon-eup, Jincheon-gun Chungcheongbuk-do
Email
ykkim@wooyoungmed.com
Authorized Representative
SRN
BE-AR-000000106
Country
Belgium
Address
53 Boulevard Gรฉnรฉral Wahis Brussels
Email
regulatory@obelis.net
Telephone
+32(2)73 25 954
Regulatory Information
Competent Authority
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
France
Market Available
France:None~None, Germany:None~None, Greece:None~None, Italy:None~None, Malta:None~None, Netherlands:None~None, Poland:None~None, Slovenia:None~None, Spain:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No