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Ultrasound Scanner - EUDAMED Registration 08809944910923

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 08809944910923 and manufactured by SAMSUNG MEDISON CO., LTD in Republic of Korea.

This page provides complete registration details including trade name (V5), 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.

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EUDAMED Official Data
Class IIa
08809944910923
Yes
Ultrasound Scanner
Trade Name: V5
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Device Description (EMDN)

INTERNAL ULTRASOUND SCANNERS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z11040101
Trade Name
V5
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
08809944910923
Basic UDI
880972578USS001X6
Version Date
October 18, 2024
Manufacturer Last Update
July 06, 2023
Active Status
Yes
Manufacturer
Manufacturer Name
SAMSUNG MEDISON CO., LTD
Country
Republic of Korea
Country Type
NON_EU
Address
3366, Hanseo-ro Gangwon-do
Email
vigilance@samsungmedison.com
Authorized Representative
SRN
DE-AR-000007005
Country
Germany
Address
2 Frankfurter Strasse Eschborn
Email
eu.vigilance@samsung.com
Telephone
+49 6196 66 0
Regulatory Information
Competent Authority
DE/CA29 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt
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