Terumo Corporation

Certificate HX 1485480-1

Rev. 0Issued

Valid until: Mar 2, 2027

Certificate HX 1485480-1 is a valid Quality management system issued to Terumo Corporation and registered in EUDAMED. Valid until March 2, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: HX 1485480-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 0197HX 1485480-10

Validity

Issued: Jun 2, 2022
Valid from: Jun 2, 2022
Valid until: Mar 2, 2027

Manufacturer

Manufacturer: Terumo Corporation
Manufacturer SRN: JP-MF-000017478
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: —
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

IVDR Class A1

1 scope

Products of class A, sterile: DEVICES FOR SAMPLES TRANSPORT (non-generic laboratory products) IVR 0803: Specimen receptacles referred to in point 2.5 (rule 5), under c), of Annex VIII to Regulation (EU) 2017/746 W050201 - SAMPLES TRANSPORT, CONTAINERS The scope of certification is limited to the aspects relating to establishing, securing and maintaining sterile conditions
IVDR Class A

Documents

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