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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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Documents

Sysmex Partec GmbH

Certificate HX 1743284-1

Rev. Rev. 1Supplemented

Valid until: Jul 18, 2028

Overview

Certificate number: HX 1743284-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 2
Certificate ID: 0197HX 1743284-1Rev. 1

Validity

Issued: Sep 17, 2025
Valid from: Sep 17, 2025
Valid until: Jul 18, 2028

Manufacturer

Manufacturer: Sysmex Partec GmbH
Manufacturer SRN: DE-MF-000019810
Manufacturer country: Germany

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: —
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable: —
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

HX 1743284-1Quality management systemIssuedJul 19, 2023 → Jul 18, 2028

Scope coverage

IVDR Class C1

1 scope

HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0506: Other devices intended to be used to determine markers of infections/immune status W01030801 - MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS IVR 0301: Devices intended to be used in screening, diagnosis, staging or monitoring of cancer W01030801 - MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS
IVDR Class C

Documents

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