Cortrium ApS

Certificate G10 098327 0006

Rev. Rev. 00Issued

Valid until: Jun 24, 2029

Certificate G10 098327 0006 is a valid Quality management system issued to Cortrium ApS and registered in EUDAMED. Valid until June 24, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: G10 098327 0006
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G10 098327 0006Rev. 00

Validity

Issued: Jun 25, 2024
Valid from: Jun 25, 2024
Valid until: Jun 24, 2029

Manufacturer

Manufacturer: Cortrium ApS
Manufacturer SRN: DK-MF-000007827
Manufacturer country: Denmark

Notified body

Notified body: TÜV SÜD Product Service GmbH
Notified body SRN: 0123
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 IIa2

2 scopes

Z12050392 - ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
Class IIa
Z12050403 - ECG HOLTER RECORDERS
Class IIa

Documents

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