Basic Information
- Number
- HZ 1194536-1
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- October 21, 2024
- Expiry Date
- September 28, 2026
- Revision
- Rev.11
- Manufacturer
- FUJIFILM Corporation
Certificate Lifecycle
Device Characteristics
Scopes
3 scopes covering 3 risk classes
Quality Procedure Scope
Z110490 - VARIOUS ULTRASOUND INSTRUMENTS The scope of certification is limited to the aspects relating to establishing, securing and maintaining sterile conditions
Quality Procedure Scope
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 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
Quality Procedure Scope
Z110390 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS VARIOUS INSTRUMENTS FOR RADIODIAGNOSTICS AND INTERVENTIONAL PROCEDURES Z110302 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS MAMMOGRAPHY SYSTEMS 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
Basic UDI-DIs
This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.