Medistim ASA

Certificate C642091

Rev. 0Issued

Valid until: Oct 14, 2029

Certificate C642091 is a valid Quality management system issued to Medistim ASA and registered in EUDAMED. Valid until October 14, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: C642091
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2460C6420910

Validity

Issued: Oct 15, 2024
Valid from: Oct 15, 2024
Valid until: Oct 14, 2029

Manufacturer

Manufacturer: Medistim ASA
Manufacturer SRN: NO-MF-000002741
Manufacturer country: Norway

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: Yes
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 IIa4

4 scopes

Medistim MiraQ Systems (Flow only)
Class IIa
Medistim MiraQ Systems (Imaging & Flow)
Class IIa
Medistim MiraQ Cardiac Systems Models: MQC0xxxx Medistim MiraQ Vascular Systems Models: MQV0xxxx Medistim MiraQ Ultimate Systems Models: MQU0xxxx
Class IIa
Medistim MiraQ Cardiac Systems with imaging Models: MQC1xxxx Medistim MiraQ Vascular Systems with imaging Models: MQV1xxxx Medistim MiraQ Ultimate Systems with imaging Models: MQU1xxxx
Class IIa

Documents

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