Novocure GmbH

Certificate HZ 1990188-1

Rev. REV2Supplemented

Valid until: Mar 23, 2027

Certificate HZ 1990188-1 is a valid Quality management system issued to Novocure GmbH and registered in EUDAMED. Valid until March 23, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 1990188-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 4
Certificate ID: 0197HZ 1990188-1REV2

Validity

Issued: Nov 10, 2025
Valid from: Nov 10, 2025
Valid until: Mar 23, 2027

Notified body

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

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: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Basic UDI-DI data and Class IIb

History

Status changes

Supplemented

Supersedes

HZ 1990188-1Quality management systemAmendedMay 15, 2025 → Mar 23, 2027

Scope coverage

Class IIb10

10 scopes

Z120402 - GENERAL MEDICINE THERAPEUTIC TREATMENTS INSTRUMENTS
Class IIb
Z119082 - VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - SOFTWARE ACCESSORIES
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb

Documents

LanguagesEN