CardioTek B.V

Certificate HZ 1700075-1

Rev. Rev. 0Issued

Valid until: Jan 22, 2030

Certificate HZ 1700075-1 is a valid Quality management system issued to CardioTek B.V and registered in EUDAMED. Valid until January 22, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 1700075-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 1700075-1Rev. 0

Validity

Issued: Jan 23, 2025
Valid from: Jan 23, 2025
Valid until: Jan 22, 2030

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
Notified body SRN: 0197
Notified body country: Germany

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 IIa1

1 scope

C010499 - ANGIOGRAPHY AND HEMODYNAMICS DEVICES – OTHER
Class IIa

Documents

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