Accufuser Omnibus
- Risk class
- Class IIb
- CND nomenclatures code
- A05010202
- Implantable
- No
- Reusable
- No
- Measuring function
- Yes
- Primary DI
- D-NSE040710XLNS
- Basic UDI
- B-NSE040710XLNS
- Version date
- November 01, 2023
- Manufacturer last update
- June 14, 2022
- Active status
- Yes
- Manufacturer name
- Woo Young Medical Co., Ltd.
- Country
- Republic of Korea
- Country type
- NON_EU
- Address
- 2 Sangsin-gil, Jincheon-eup, Jincheon-gun Chungcheongbuk-do
- ykkim@wooyoungmed.com
- Name
- Obelis s.a.
- SRN
- BE-AR-000000106
- Country
- Belgium
- Address
- 53 Boulevard Général Wahis Brussels
- regulatory@obelis.net
- Telephone
- +32(2)73 25 954
- 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
- Human tissues
- No
- Animal tissues
- No
ELASTOMERIC SYSTEMS - VARIABLE FLOW WITH ADDITIONAL BOLUS
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-NSE040710XLNS 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.