OLYMPUS MEDICAL SYSTEMS CORP.

Certificate DZ 2158445-1

Rev. Rev.3Supplemented

Valid until: Jan 19, 2028

Certificate DZ 2158445-1 is a valid Quality assurance issued to OLYMPUS MEDICAL SYSTEMS CORP. and registered in EUDAMED. Valid until January 19, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: DZ 2158445-1
Certificate type: Quality assurance
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197DZ 2158445-1Rev.3

Validity

Issued: Oct 24, 2024
Valid from: Oct 24, 2024
Valid until: Jan 19, 2028

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: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

DZ 2158445-1Quality assuranceIssuedNov 14, 2023 → Jan 19, 2028

Scope coverage

Class I1

1 scope

Z120290 - VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY Z120204 - INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES The scope of certification is limited to the aspects relating to establishing, securing and maintaining sterile conditions
Class I

Documents

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