FUJIFILM Corporation

Certificate HZ 1194536-1

Rev. Rev.13Supplemented

Valid until: Sep 28, 2026

Certificate HZ 1194536-1 — a Quality management system issued to FUJIFILM Corporation — is approaching its expiry. Valid until September 28, 2026. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 1194536-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 0197HZ 1194536-1Rev.13

Validity

Issued: Dec 24, 2025
Valid from: Dec 24, 2025
Valid until: Sep 28, 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: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

HZ 1194536-1Quality management systemSupplementedFeb 20, 2025 → Sep 28, 2026

Scope coverage

Class IIa3Class IIb2Class I1

6 scopes

Z110490 - VARIOUS ULTRASOUND INSTRUMENTS The scope of certification is limited to the aspects relating to establishing, securing and maintaining sterile conditions
Class I
Z120206 - LOWER GASTROINTESTINAL TRACT ENDOSCOPY INSTRUMENTS Z120204 - ACQUISITION AND MANAGEMENT INSTRUMENTS FOR ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES Z120782 - GASTROENTEROLOGY INSTRUMENTS - SOFTWARE Z110311 - DIRECT DIGITAL RADIOLOGY (DR) SYSTEMS
Class IIa
Z110390 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS VARIOUS INSTRUMENTS FOR RADIODIAGNOSTICS AND INTERVENTIONAL PROCEDURES Z110302 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS MAMMOGRAPHY SYSTEMS
Class IIb
Z110690 - VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS Z120205 - UPPER GASTROINTESTINAL TRACT ENDOSCOPY INSTRUMENTS Z120208 - PULMONARY ENDOSCOPIC INSTRUMENTS Z110402 - ULTRASOUND PROBES Z110401 - ULTRASOUND SCANNERS Z120290 - VARIOUS ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY INSTRUMENTS Z120210 - ENT ENDOSCOPY INSTRUMENTS Z110602 - DIGITAL COMPUTED RADIOGRAPHY (CR) SYSTEMS Z110501 - MAGNETIC RESONANCE (MR) SYSTEMS Z110490 - VARIOUS ULTRASOUND INSTRUMENTS
Class IIa
Z110306 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS COMPUTED TOMOGRAPHS (CT) Z110307 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS REMOTE CONTROL TABLES Z11039012 - VARIOUS INSTRUMENTS FOR RADIODIAGNOSTICS AND INTERVENTIONAL PROCEDURES X-RAY TUBE ASSEMBLY Z120792 - GASTROENTEROLOGICAL INSTRUMENTS GASTROENTEROLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE G030301 - POLYPECTOMY DEVICES POLYPECTOMY SNARES
Class IIb
G030899 - INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER R0799 - BRONCOPULMONARY ENDOSCOPY DEVICES, SINGLE-USE - OTHER
Class IIa

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