Philips Medical Systems Nederland B.V.

Certificate HZ 1135905-1

Rev. Rev. 2Issued

Valid until: Jun 4, 2030

Certificate HZ 1135905-1 is a valid Quality management system issued to Philips Medical Systems Nederland B.V. and registered in EUDAMED. Valid until June 4, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 1135905-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 1135905-1Rev. 2

Validity

Issued: Jun 3, 2025
Valid from: Jun 5, 2025
Valid until: Jun 4, 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: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb1

1 scope

Z110306 - Diagnostic and Interventional Radiology Instruments Computed Tomographs (CT) Z110203 - Nuclear Medicine Instruments Integrated CT/PET Systems
Class IIb

Documents

LanguagesEN