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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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MD Atlas
Documents

Systolé Hardware B.V.

Certificate HZ 1147806-1

Rev. Rev. 0Cancelled

Valid until: Apr 29, 2030

Overview

Certificate number: HZ 1147806-1
Certificate type: Quality management system
Certificate status: Cancelled
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 1147806-1Rev. 0

Validity

Issued: Apr 30, 2025
Valid from: Apr 30, 2025
Valid until: Apr 29, 2030

Manufacturer

Manufacturer: Systolé Hardware B.V.
Manufacturer SRN: NL-MF-000006605
Manufacturer country: Netherlands

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: No
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

Status changes

Cancelled

Supersedes

HZ 1147806-1Quality management systemIssuedApr 30, 2025 → Apr 29, 2030

Scope coverage

Class IIa1

1 scope

Z12050403 - ECG HOLTER RECORDERS
Class IIa

Documents

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