Vitalthings AS

Certificate MDR-0017

Rev. 2Amended

Valid until: Sep 30, 2029

Certificate MDR-0017 is a valid Quality management system issued to Vitalthings AS and registered in EUDAMED. Valid until September 30, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: MDR-0017
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 1304MDR-00172

Validity

Issued: Feb 26, 2026
Valid from: Feb 26, 2026
Valid until: Sep 30, 2029

Notified body

Notified body: SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ
Notified body SRN: 1304
Notified body country: Slovenia

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: No
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: No
QMS/MOS type: Class IIb only

History

Status changes

Amended

Supersedes

MDR-0017Quality management systemIssuedOct 1, 2024 → Sep 30, 2029

Scope coverage

Class IIb4

4 scopes

Multi-parameter patient bedside monitors
Class IIb
Transportable/Portable Multi-parameter patient monitors
Class IIb
Vitalthings Guardian M10, Stationary
Class IIb
Vitalthings Guardian M10, Mobile
Class IIb

Documents

LanguagesEN