Terumo Corporation

Certificate HZ 1485480-1

Rev. 26Supplemented

Valid until: May 28, 2030

Certificate HZ 1485480-1 is a valid Quality management system issued to Terumo Corporation and registered in EUDAMED. Valid until May 28, 2030. 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: 2
Certificate ID: 0197HZ 1485480-126

Validity

Issued: May 21, 2026
Valid from: May 21, 2026
Valid until: May 28, 2030

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
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: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

HZ 1485480-1Quality management systemReissuedApr 25, 2025 → May 28, 2030

Scope coverage

Class IIa16Class IIb5Class III3Class I2

26 scopes

B019004 - BLOOD COMPONENTS SAMPLING BAGS AND KITS The scope of certification is limited to the aspects relating to establishing, securing and maintaining sterile conditions
Class I
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
Class IIa
A020102 - INFUSION AND IRRIGATION SYRINGES, SINGLE-USE
Class IIa
C010101 - PERIPHERAL I.V. CATHETERS
Class IIa
C030101 - EXTRACORPOREAL CIRCULATION KITS
Class IIa
Z121799 - BLOOD TRANSFUSION INSTRUMENTS - OTHER
Class IIa
A010102 - BUTTERFLY NEEDLES
Class IIa
A019099 - NEEDLES FOR OTHER PROCEDURES - OTHER
Class IIa
G0399 - DIGESTIVE ENDOSCOPY DEVICES - OTHER
Class IIa
C040201 - PERIPHERAL VASCULAR DIAGNOSTICGUIDE WIRES
Class IIa
C040202 - PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES
Class IIa
C0504 - ARTERIAL INTRODUCTION SETS
Class IIa
A020199 - SYRINGES, SINGLE-USE - OTHER
Class IIa
C010402 - PERIPHERAL ANGIOGRAPHY DEVICES
Class IIa
B020101 - BED-SIDE LEUKOREDUCTION FILTERS
Class IIa
V010402 - LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE
Class IIa
U0601 - UROLOGICAL GUIDEWIRES, HYDROPHILIC
Class IIa
B010202 - BLOOD TRANSFER BAGS AND KITS PLATELETS CONCENTRATE TRANSFER BAGS AND KITS
Class IIb
B010201 - BLOOD TRANSFER BAGS AND KITS WHOLE BLOOD, RED BLOOD CELLS OR PLASMA TRANSFER BAGS AND KITS
Class IIb

1 / 2

Documents

LanguagesEN

Scope coverage

Class IIa16Class IIb5Class III3Class I2

26 scopes

B019004 - BLOOD COMPONENTS SAMPLING BAGS AND KITS The scope of certification is limited to the aspects relating to establishing, securing and maintaining sterile conditions
Class I
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
Class IIa
A020102 - INFUSION AND IRRIGATION SYRINGES, SINGLE-USE
Class IIa
C010101 - PERIPHERAL I.V. CATHETERS
Class IIa
C030101 - EXTRACORPOREAL CIRCULATION KITS
Class IIa
Z121799 - BLOOD TRANSFUSION INSTRUMENTS - OTHER
Class IIa
A010102 - BUTTERFLY NEEDLES
Class IIa
A019099 - NEEDLES FOR OTHER PROCEDURES - OTHER
Class IIa
G0399 - DIGESTIVE ENDOSCOPY DEVICES - OTHER
Class IIa
C040201 - PERIPHERAL VASCULAR DIAGNOSTICGUIDE WIRES
Class IIa
C040202 - PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES
Class IIa
C0504 - ARTERIAL INTRODUCTION SETS
Class IIa
A020199 - SYRINGES, SINGLE-USE - OTHER
Class IIa
C010402 - PERIPHERAL ANGIOGRAPHY DEVICES
Class IIa
B020101 - BED-SIDE LEUKOREDUCTION FILTERS
Class IIa
V010402 - LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE
Class IIa
U0601 - UROLOGICAL GUIDEWIRES, HYDROPHILIC
Class IIa
B010202 - BLOOD TRANSFER BAGS AND KITS PLATELETS CONCENTRATE TRANSFER BAGS AND KITS
Class IIb
B010201 - BLOOD TRANSFER BAGS AND KITS WHOLE BLOOD, RED BLOOD CELLS OR PLASMA TRANSFER BAGS AND KITS
Class IIb

1 / 2

Certificate HZ 1485480-1

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate HZ 1485480-1

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer