TERUMO EUROPE N.V.

Certificate HZ 1594584-1

Rev. 5Supplemented

Valid until: Dec 31, 2026

Certificate HZ 1594584-1 is a valid Quality management system issued to TERUMO EUROPE N.V. and registered in EUDAMED. Valid until December 31, 2026. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 1594584-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 7
Certificate ID: 0197HZ 1594584-15

Validity

Issued: Aug 23, 2025
Valid from: Aug 23, 2025
Valid until: Dec 31, 2026

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: No
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: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

HZ 1594584-1Quality management systemSupplementedJun 20, 2025 → Dec 31, 2026

Scope coverage

Class III8Class IIa7

15 scopes

C0104010202 - CARDIAC ANGIOGRAPHY GUIDE CATHETERS
Class III
C0104020101 - PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS
Class III
C0104020204 - PERIPHERAL ANGIOGRAPHY GUIDE CATHETERS
Class III
C0104010101 - CARDIAC ANGIOGRAPHY DIAGNOSTIC CATHETERS
Class III
A010101 - HYPERDERMIC NEEDLES
Class IIa
A020199 - SYRINGES - OTHERS
Class IIa
A010102 - BUTTERFLY NEEDLES
Class IIa
U0601 UROLOGICAL GUIDEWIRES, HYDROPHILIC
Class IIa
C0504 ARTERIAL INTRODUCTION SETS
Class IIa
G0399 DIGESTIVE ENDOSCOPY DEVICES – OTHER
Class IIa
A010599 OPTHALMOLOGY INJECTION NEEDLES AND KITS – OTHER
Class IIa
C01040201 – PERIPHERAL ANGIOGRAPHY DIAGNOSTIC DEVICES
Class III
C01040202 – PERIPHERAL ANGIOGRAPY THERAPEUTIC DEVICES
Class III
C04030101 - DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC
Class III
C04030201 - INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC
Class III

Documents

LanguagesEN

Scope coverage

Class III8Class IIa7

15 scopes

C0104010202 - CARDIAC ANGIOGRAPHY GUIDE CATHETERS
Class III
C0104020101 - PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS
Class III
C0104020204 - PERIPHERAL ANGIOGRAPHY GUIDE CATHETERS
Class III
C0104010101 - CARDIAC ANGIOGRAPHY DIAGNOSTIC CATHETERS
Class III
A010101 - HYPERDERMIC NEEDLES
Class IIa
A020199 - SYRINGES - OTHERS
Class IIa
A010102 - BUTTERFLY NEEDLES
Class IIa
U0601 UROLOGICAL GUIDEWIRES, HYDROPHILIC
Class IIa
C0504 ARTERIAL INTRODUCTION SETS
Class IIa
G0399 DIGESTIVE ENDOSCOPY DEVICES – OTHER
Class IIa
A010599 OPTHALMOLOGY INJECTION NEEDLES AND KITS – OTHER
Class IIa
C01040201 – PERIPHERAL ANGIOGRAPHY DIAGNOSTIC DEVICES
Class III
C01040202 – PERIPHERAL ANGIOGRAPY THERAPEUTIC DEVICES
Class III
C04030101 - DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC
Class III
C04030201 - INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC
Class III

Certificate HZ 1594584-1

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate HZ 1594584-1

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer