Ultrasound Scanner
- Risk class
- Class IIa
- CND nomenclatures code
- Z11040101
- Trade name
- RS85
- Implantable
- No
- Reusable
- No
- Measuring function
- Yes
- Primary DI
- 08809944886846
- Basic UDI
- 880972578USS001X6
- Version date
- September 02, 2024
- Manufacturer last update
- July 06, 2023
- Active status
- Yes
- Manufacturer name
- SAMSUNG MEDISON CO., LTD
- Country
- Republic of Korea
- Country type
- NON_EU
- Address
- 3366, Hanseo-ro Gangwon-do
- vigilance@samsungmedison.com
- SRN
- DE-AR-000007005
- Country
- Germany
- Address
- 6 Am Kronberger Hang Schwalbach
- eu.vigilance@samsung.com
- Telephone
- +49 6196 66 5371
- Competent authority
- DE/CA29 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt
- Applicable legislation
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Placed on the market
- Romania
- 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
- Human tissues
- No
- Animal tissues
- No
INTERNAL ULTRASOUND SCANNERS
Access comprehensive regulatory information for Ultrasound Scanner in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 08809944886846 and manufactured by SAMSUNG MEDISON CO., LTD in Republic of Korea.
This page provides complete registration details including trade name (RS85), manufacturer information, authorized representative details, competent authority (DE/CA29 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt), 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.