FUJIFILM Corporation

Certificate HZ 1194536-2

Rev. 1Reissued

Valid until: Jul 12, 2031

Certificate HZ 1194536-2 is a valid Quality management system issued to FUJIFILM Corporation and registered in EUDAMED. Valid until July 12, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 1194536-2
Certificate type: Quality management system
Certificate status: Reissued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 1194536-21

Validity

Issued: Jun 9, 2026
Valid from: Jul 13, 2026
Valid until: Jul 12, 2031

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

History

Supersedes

HZ 1194536-2Quality management systemIssuedDec 24, 2025 → Jul 12, 2026

Scope coverage

Class I1

1 scope

K010201 - MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENTS, SINGLE-USE
Class I

Documents

LanguagesEN