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ECG Android - EUDAMED Registration 08806092938823

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 08806092938823 and manufactured by Samsung Electronics Co., Ltd. in Republic of Korea.

This page provides complete registration details including trade name (ECG Wear OS (v1.1)), 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
08806092938823
Yes
ECG Android
Trade Name: ECG Wear OS (v1.1)
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Device Description (EMDN)

ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z12050382
Trade Name
ECG Wear OS (v1.1)
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
08806092938823
Basic UDI
88060940602706J
Version Date
August 03, 2023
Manufacturer Last Update
June 21, 2022
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
6 Am Kronberger Hang Schwalbach/ Ts.
Email
eu.vigilance@samsung.com
Telephone
+49 6196 66 5371
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:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No