Terumo Corporation

Certificate HZ 1485480-1

Rev. Rev.24Supplemented

Valid until: May 28, 2025

Certificate HZ 1485480-1, a Quality management system issued to Terumo Corporation, has expired. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 1485480-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 0197HZ 1485480-1Rev.24

Validity

Issued: Dec 18, 2024
Valid from: Dec 18, 2024
Valid until: May 28, 2025

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

History

Status changes

Supplemented

Supersedes

HZ 1485480-1Quality management systemSupplementedDec 10, 2024 → May 28, 2025

Scope coverage

Class I1Class IIa1Class IIb1Class III1

4 scopes

B019004 - BLOOD COMPONENTS SAMPLING BAGS AND KITS C900103 - PERCUTANEOUS ARTERIAL ACCESS HAEMOSTASIS SYSTEMS The scope of certification is limited to the aspects relating to establishing, securing and maintaining sterile conditions
Class I
A010101 - HYPODERMIC NEEDLES A020102 - INFUSION AND IRRIGATION SYRINGES, SINGLE-USE C010101 - PERIPHERAL I.V. CATHETERS C030101 - EXTRACORPOREAL CIRCULATION KITS Z121799 - BLOOD TRANSFUSION INSTRUMENTS - OTHER A010102 - BUTTERFLY NEEDLES A019099 - NEEDLES FOR OTHER PROCEDURES - OTHER G0399 - DIGESTIVE ENDOSCOPY DEVICES - OTHER C040201 - PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES C040202 - PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES C0504 - ARTERIAL INTRODUCTION SETS A020199 - SYRINGES, SINGLE-USE - OTHER C010402 - PERIPHERAL ANGIOGRAPHY DEVICES B020101 - BED-SIDE LEUKOREDUCTION FILTERS V010402 - LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE
Class IIa
B010202 - BLOOD TRANSFER BAGS AND KITS PLATELETS CONCENTRATE TRANSFER BAGS AND KITS Intended Purpose: TERUFLEX BP-KIT with IMUGARD III-SPL is intended for pooling up to six buffy-coats, for in process filtration and preservation of leukocyte removed platelet concentrate. B010202 - BLOOD TRANSFER BAGS AND KITS PLATELETS CONCENTRATE TRANSFER BAGS AND KITS Intended Purpose: TERUFLEX BP-KIT is intended for pooling up to six buffy-coats, for in process separation and preservation of platelet concentrates. B010201 - BLOOD TRANSFER BAGS AND KITS WHOLE BLOOD, RED BLOOD CELLS OR PLASMA TRANSFER BAGS AND KITS Intended Purpose: TERUFLEX TRANSFER BAG is intended for separating and storing each blood component. Z120303 - INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS INFUSION INSTRUMENTS Intended Purpose: TERUFUSION TE-18 is an infusion pump intended for the controlled delivery of parenteral nutrition, fluid maintenance, which is conducted by healthcare professionals, in a clinical environment. B020102 – LEUKOREDUCTION FILTERS LABORATORY LEUKOREDUCTION FILTERS Intended Purpose: IMUGARD III-RC is intended for the removal of leukocytes from a single unit of packed red blood cells or whole blood. B010102 - BLOOD COLLECTION BAGS AND KITS HOMOLOGOUS DONOR BLOOD COLLECTION BAGS AND KITS
Class IIb
C010401 - ANGIOGRAPHY AND HAEMODYNAMIC DEVICES CARDIAC ANGIOGRAPHY DEVICES Intended Purpose: Use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system. It is also used to lead a guide wire or a catheter into the target site. C0504 - CARDIOVASCULAR INTRODUCER SHEATHS ARTERIAL INTRODUCTION SETS Intended Purpose: The device is intended to be inserted percutaneously into a vessel to facilitate the insertion of angiographic, electrode, balloon, or similar catheters. C0499 - CARDIOVASCULAR GUIDEWIRES CARDIOVASCULAR GUIDEWIRES – OTHER Intended Purpose: The device is intended to direct a catheter to the desired anatomical location in the vascular system during diagnostic or interventional procedures.
Class III

Documents

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