Terumo Medical Corporation

Certificate HZ 1191937-1

Rev. 0Issued

Valid until: Mar 8, 2031

Certificate HZ 1191937-1 is a valid Quality management system issued to Terumo Medical Corporation and registered in EUDAMED. Valid until March 8, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 1191937-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 1191937-10

Validity

Issued: Mar 9, 2026
Valid from: Mar 9, 2026
Valid until: Mar 8, 2031

Manufacturer

Manufacturer: Terumo Medical Corporation
Manufacturer SRN: US-MF-000026109
Manufacturer country: United States

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: Yes
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class III1

1 scope

C0502 - CARDIOVASCULAR INTRODUCER SHEATHS, VALVED The Destination Guiding Sheath is intended to be inserted percutaneously over a guidewire into the arterial vasculature to facilitate the introduction of interventional and diagnostic devices.
Class III

Documents

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