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ECG Android - EUDAMED Registration 08806094940763

Access comprehensive regulatory information for ECG Android 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 08806094940763 and manufactured by Samsung Electronics Co., Ltd. in Republic of Korea.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (DE/CA29 - Regierungsprรคsidium 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
08806094940763
Yes
ECG Android
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z12040182
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
08806094940763
Basic UDI
88060940602706J
Version Date
December 26, 2024
Manufacturer Last Update
October 17, 2023
Active Status
Yes
Manufacturer
Country
Republic of Korea
Country Type
NON_EU
Address
129 Samsung-ro Suwon-si
Email
vigilance.md@samsung.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 - Regierungsprรคsidium Darmstadt Abteilung Arbeitsschutz und Umwelt
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Germany:2025-01-06~None
Device Characteristics
Human Tissues
No
Animal Tissues
No