Samsung Electronics Co., Ltd.

Certificate 10000493907-PA-NoMA-KOR

Rev. 2Issued

Valid until: Apr 3, 2028

Certificate 10000493907-PA-NoMA-KOR is a valid Quality management system issued to Samsung Electronics Co., Ltd. and registered in EUDAMED. Valid until April 3, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 10000493907-PA-NoMA-KOR
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 246010000493907-PA-NoMA-KOR2

Validity

Issued: Apr 3, 2023
Valid from: Apr 3, 2023
Valid until: Apr 3, 2028

Manufacturer

Manufacturer: Samsung Electronics Co., Ltd.
Manufacturer SRN: KR-MF-000023537
Manufacturer country: South Korea

Notified body

Notified body
Notified body SRN: 2460
Notified body country: Norway

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa6

6 scopes

Samsung Health Monitor application – Blood Pressure Application
Class IIa
Samsung Health Monitor application – ECG Application
Class IIa
Samsung Health Monitor application – Sleep Apnea Application
Class IIa
Blood Pressure App BP-Android, BP-Tizen, BP-Wear OS
Class IIa
ECG App ECG-Android, ECG-Tizen, ECG-Wear OS
Class IIa
Sleep Apnea Feature Sleep Apnea-Android, Sleep Apnea-Wear OS
Class IIa

Documents

LanguagesEN