PulseOn Oy

Certificate CR-03-1224-781-22

Rev. 01Issued

Valid until: Feb 25, 2027

Certificate CR-03-1224-781-22 is a valid Quality management system issued to PulseOn Oy and registered in EUDAMED. Valid until February 25, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: CR-03-1224-781-22
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0537CR-03-1224-781-2201

Validity

Issued: Feb 24, 2022
Valid from: Feb 25, 2022
Valid until: Feb 25, 2027

Manufacturer

Manufacturer: PulseOn Oy
Manufacturer SRN: FI-MF-000009325
Manufacturer country: Finland

Notified body

Notified body: Eurofins Electric & Electronics Finland Oy
Notified body SRN: 0537
Notified body country: Finland

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: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
Class IIa
PulseOn Arrhythmia Monitor System
Class IIa

Documents

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