Basic Information
- Number
- HZ 2158445-1
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- February 9, 2024
- Expiry Date
- March 25, 2026 Expired
- Revision
- Rev.12
- Manufacturer
- OLYMPUS MEDICAL SYSTEMS CORP.
Certificate Lifecycle
Device Characteristics
Scopes
2 scopes covering 2 risk classes
Quality Procedure Scope
Z120204 - INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES A019007 - SCLEROTHERAPY NEEDLES AND KITS G030801 - GASTROINTESTINAL ENDOSCOPY, FORCEPS, SINGLE-USE G0380 - DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES Z120782 - GASTROENTEROLOGY INSTRUMENTS - SOFTWARE ACCESSORIES R070201 - BRONCHOSCOPIC SURGERY FORCEPS, SINGLE-USE U090301 - FORCEPS FOR UROGENITAL ENDOSCOPY, SINGLE-USE Z110401 - ULTRASOUND SCANNERS Z120290 - VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY K010201 - MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENTS, SINGLE-USE G030501 - DIGESTIVE ENDOSCOPY, RETRIEVAL DEVICES Z120205 - UPPER GASTROINTESTINAL TRACT ENDOSCOPY INSTRUMENTS Z120206 - LOWER GASTROINTESTINAL TRACT ENDOSCOPY INSTRUMENTS Z120208 - PULMONARY ENDOSCOPIC INSTRUMENTS Z120207 - GENITOURINARY ENDOSCOPY INSTRUMENTS Z120210 - ENT ENDOSCOPY INSTRUMENTS
Quality Procedure Scope
Z120204 - INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES Z120108 - GENERAL AND MULTIDISCIPLINARY SURGERY INSTRUMENTS INSTRUMENTS FOR ULTRASONIC SURGERY Z120109 - GENERAL AND MULTIDISCIPLINARY SURGERY INSTRUMENTS ELECTROSURGICAL INSTRUMENTS
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.