ECG Android
- Risk class
- Class IIa
- CND nomenclatures code
- Z12050382
- Trade name
- ECG Wear OS (v1.1)
- Implantable
- No
- Reusable
- No
- Measuring function
- Yes
- Primary DI
- 08806092938823
- Basic UDI
- 88060940602706J
- Version date
- August 03, 2023
- Manufacturer last update
- June 21, 2022
- Active status
- Yes
- Manufacturer name
- Samsung Electronics Co., Ltd.
- Country
- Republic of Korea
- Country type
- NON_EU
- Address
- 129 Samsung-ro Suwon-si
- vigilance.md@samsung.com
- SRN
- DE-AR-000007005
- Country
- Germany
- Address
- 6 Am Kronberger Hang Schwalbach/ Ts.
- 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
- Germany
- Market available
- Germany:None~None
- Human tissues
- No
- Animal tissues
- No
ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES
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 - 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.