OLYMPUS MEDICAL SYSTEMS CORP.

Certificate HZ 2158445-1

Rev. Rev.14Reissued

Valid until: Mar 25, 2031

Certificate HZ 2158445-1 is a valid Quality management system issued to OLYMPUS MEDICAL SYSTEMS CORP. and registered in EUDAMED. Valid until March 25, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2158445-1
Certificate type: Quality management system
Certificate status: Reissued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 2158445-1Rev.14

Validity

Issued: Feb 27, 2026
Valid from: Mar 26, 2026
Valid until: Mar 25, 2031

Manufacturer

Manufacturer: OLYMPUS MEDICAL SYSTEMS CORP.
Manufacturer SRN: JP-MF-000008016
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

Supersedes

HZ 2158445-1Quality management systemSupplementedMay 26, 2025 → Mar 25, 2026

Scope coverage

Class IIa3Class IIb1

4 scopes

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 R070201 - BRONCHOSCOPIC SURGERY FORCEPS, SINGLE-USE U090301 - FORCEPS FOR UROGENITAL ENDOSCOPY, SINGLE-USE Z110401 - ULTRASOUND SCANNERS
Class IIa
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
Class IIb
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
Class IIa
Z120207 - GENITOURINARY ENDOSCOPY INSTRUMENTS Z120210 - ENT ENDOSCOPY INSTRUMENTS Z120792 - GASTROENTEROLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
Class IIa

Documents

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