Ortivus MobiMed AB

Certificate 28620161156

Rev. 00Issued

Valid until: Nov 27, 2028

Certificate 28620161156 is a valid Quality management system issued to Ortivus MobiMed AB and registered in EUDAMED. Valid until November 27, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 28620161156
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 28622862016115600

Validity

Issued: Nov 28, 2023
Valid from: Nov 28, 2023
Valid until: Nov 27, 2028

Notified body

Notified body: Intertek Medical Notified Body AB
Notified body SRN: 2862
Notified body country: Sweden

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: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Basic UDI-DI data and Class IIb

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb2

2 scopes

Patient monitoring devices
Class IIb
DEVICE
Class IIb

Documents

LanguagesEN