Otivio AS

Certificate C576271

Rev. 0Issued

Valid until: Aug 29, 2029

Certificate C576271 is a valid Quality management system issued to Otivio AS and registered in EUDAMED. Valid until August 29, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: C576271
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2460C5762710

Validity

Issued: Aug 30, 2024
Valid from: Aug 30, 2024
Valid until: Aug 29, 2029

Notified body

Notified body: DNV Product Assurance AS
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: 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

Blood Flow Enhancement System
Class IIa
FlowOX™ 2.0
Class IIa

Documents

LanguagesEN