FUJIFILM Corporation

Certificate HZ 1194536-2

Rev. Rev.0Issued

Valid until: Jul 12, 2026

Certificate HZ 1194536-2 — a Quality management system issued to FUJIFILM Corporation — is approaching its expiry. Valid until July 12, 2026. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 1194536-2
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 1194536-2Rev.0

Validity

Issued: Dec 24, 2025
Valid from: Dec 24, 2025
Valid until: Jul 12, 2026

Manufacturer

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
Manufacturer country: Japan

Notified body

Notified body
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: Yes
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class I1

1 scope

K010201 - MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENTS, SINGLE-USE The scope of certification is limited to the aspects relating to establishing, securing and maintaining sterile conditions
Class I

Documents

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