FUJIFILM Corporation

Certificate 4203162CE01

Rev. 1Amended

Valid until: Jun 27, 2029

Certificate 4203162CE01 is a valid Quality management system issued to FUJIFILM Corporation and registered in EUDAMED. Valid until June 27, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 4203162CE01
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 03444203162CE011

Validity

Issued: Jul 15, 2024
Valid from: Jul 15, 2024
Valid until: Jun 27, 2029

Notified body

Notified body: DEKRA Certification B.V.
Notified body SRN: 0344
Notified body country: Netherlands

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Basic UDI-DI data only

History

Status changes

Amended

Supersedes

4203162CE01IssuedJun 27, 2024 → Jun 27, 2029

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa1

1 scope

DEVICE
Class IIa

Documents

LanguagesEN