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Safety and performance information

This website contains safety and performance information of products manufactured by Terumo Europe N.V. / Quirem Medical B.V. that are certified under the Medical Device Regulation (EU) 2017/745 (Annex I, chapter III, 23.1 general requirements)

Product type
Guide wires
Imaging software
Introducers
Microspheres
Needles
Stents
Syringes
Winged infusion sets
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 Revision 4

Safety and performance information - Q-Suite™

In this document you will find safety and performance information as covered in the Instructions for Use for the product: Q-Suite™ 2.2 Imaging software

 Revision 3

Safety and performance information - Q-Suite™

Q-Suite™2.1: Historic version - device certified under Medical Device Directive 93/42/EEC

 Revision 2

Safety and performance information - RADIFOCUS™ Guide Wire M Non-Vascular

In this document you will find safety and performance information as covered in the Instructions for Use for the product: RADIFOCUS™ Guide Wire M Non-Vascular - Non-vascular guide wire

 Revision 2

Safety and performance information - Q-Suite™

Q-Suite™2.0 -Historic version - device certified under Medical Device Directive 93/42/EEC

 Revision 2

Safety and performance information - K-Pack Surshield™ Needle

In this document you will find safety and performance information as covered in the Instructions for Use for the product: K-Pack Surshield™ Needle

 Revision 2

Safety and performance information - Ultimaster Nagomi™

In this document you will find safety and performance information as covered in the Instructions for Use for the product: Ultimaster Nagomi™ Sirolimus eluting coronary stent system

 Revision 2

Safety and performance information - Surflo™ Winged Infusion Set with Needle Protection

In this document you will find safety and performance information as covered in the Instructions for Use for the product: Surflo™ Winged Infusion Set with Needle Protection

 Revision 2

Safety and performance information - Surflo™ Winged Infusion Set with Filter and Needle Protection

In this document you will find safety and performance information as covered in the Instructions for Use for the product: Surflo™ Winged Infusion Set with Filter and Needle Protection

 Revision 1

Safety and performance information - RADIFOCUS™ Guide Wire M Non-Vascular

In this document you will find safety and performance information as covered in the Instructions for Use for the product: RADIFOCUS™ Guide Wire M Non-Vascular - Non-vascular guide wire

 Revision 1

Safety and performance information - Q-Suite™

Q-Suite™1.2 -Historic version - device certified under Medical Device Directive 93/42/EEC

 Revision 1

Safety and performance information - RADIFOCUS™ Introducer II

In this document you will find safety and performance information as covered in the Instructions for Use for the product: RADIFOCUS™ Introducer II - Introducer for radial access

 Revision 1

Safety and performance information - QuiremSpheres™

In this document you will find safety and performance information as covered in the Instructions for Use for the product: QuiremSpheres™ Holmium-166 PLLA microspheres

 Revision 1

Safety and performance information - QuiremScout™

In this document you will find safety and performance information as covered in the Instructions for Use for the product: QuiremScout™ Holmium-166 PLLA microspheres

 Revision 1

Patient information - Video - QuiremSpheres™

In this video you will find all relevant information on your implant: QuiremSpheres™ Holmium-166 PLLA microspheres

 Revision 1

Patient information - Video - QuiremScout™

In this video you will find all relevant information on your implant: QuiremScout™ Holmium-166 PLLA microspheres

 Revision 1

Safety and performance information - QuiremSpheres™ Customer Kit

In this document you will find safety and performance information as covered in the Instructions for Use for the product: QuiremSpheres™ Customer Kit

 Revision 1

Patient information - QuiremScout™

In this document you will find all relevant information on your implant: QuiremScout™ Holmium-166 PLLA microspheres

 Revision 1

Safety and performance information - Manual - QuiremScout™

In this manual you can find safety and performance information related to the administration procedure of QuiremScout™ Holmium-166 PLLA microspheres

 Revision 1

Safety and performance information - Manual - QuiremSpheres™

In this manual you can find safety and performance information related to the administration procedure of QuiremSpheres™ Holmium-166 PLLA microspheres

 Revision 1

Patient information - QuiremSpheres™

In this document you will find all relevant information on your implant: QuiremSpheres™ Holmium-166 PLLA microspheres

 Revision 1

Safety and performance information - K-Pack™ II Needle

In this document you will find safety and performance information for the product: K-Pack™ II Needle

 Revision 1

Safety and performance information - Neolus™ Needle

In this document you will find safety and performance information for the product: Neolus™ Needle

 Revision 1

Safety and performance information - K-Pack Surshield™ Needle

In this document you will find safety and performance information as covered in the Instructions for Use for the product: K-Pack Surshield™ Needle

 Revision 1

Safety and performance information - SurGuard™3 Safety Hypodermic Needle

In this document you will find safety and performance information as covered in the Instructions for Use for the product: SurGuard™3 Safety Hypodermic Needle

 Revision 1

Safety and performance information - Terumo Injection Filter Needle

In this document you will find safety and performance information as covered in the Instructions for Use for the product: Terumo Injection Filter Needle

 Revision 1

Safety and performance information - K-Pack Embrace™ Active Safety Needle

In this document you will find safety and performance information as covered in the Instructions for Use for the product: K-Pack Embrace™ Active Safety Needle

 Revision 1

Safety and performance information - Ultimaster Nagomi™

In this document you will find safety and performance information as covered in the Instructions for Use for the product: Ultimaster Nagomi™ Sirolimus eluting coronary stent system

 Revision 1

MRI information - Ultimaster Nagomi™

In this document you will find the Magnetic Resonance Imaging (MRI) conditions to allow safe scanning of your patient implanted with Ultimaster Nagomi™ Sirolimus eluting coronary stent system.

 Revision 1

Patient information - Ultimaster Nagomi™

In this document you will find all relevant information on your implant: Ultimaster Nagomi™ Sirolimus eluting coronary stent system

 Revision 1

Safety and performance information - Terumo Syringe with Fixed Needle Gonal-f Multi-Dose 600 IU/ml FSH

In this document you will find safety and performance information as covered in the Instructions for Use for the product: Terumo Syringe with Fixed Needle Gonal-f Multi-Dose 600 IU/ml FSH

 Revision 1

Safety and performance information - Terumo Syringe with Fixed Needle MENOPUR Multidose 600 IU/ml FSH/LH

In this document you will find safety and performance information as covered in the Instructions for Use for the product: Terumo Syringe with Fixed Needle MENOPUR Multidose 600 IU/ml FSH/LH

 Revision 1

Safety and performance information - Terumo Syringe with Fixed Needle 600 IU/ml FSH

In this document you will find safety and performance information as covered in the Instructions for Use for the product: Terumo Syringe with Fixed Needle 600 IU/ml FSH

 Revision 1

Safety and performance information - Terumo Syringe with Fixed Needle Folisurge 600 IU/0.96ml FSH

In this document you will find safety and performance information as covered in the Instructions for Use for the product: Terumo Syringe with Fixed Needle Folisurge 600 IU/0.96ml FSH

 Revision 1

Safety and performance information - Terumo Syringe with Fixed Needle 1 mg/0.2 ml leuprolide acetate

In this document you will find safety and performance information as covered in the Instructions for Use for the product: Terumo Syringe with Fixed Needle 1 mg/0.2 ml leuprolide acetate

 Revision 1

Safety and performance information - Surflo™ Winged Infusion Set with Filter and Needle Protection

In this document you will find safety and performance information as covered in the Instructions for Use for the product: Surflo™ Winged Infusion Set with Filter and Needle Protection

 Revision 1

Safety and performance information - Surflo™ Winged Infusion Set with Needle Protection

In this document you will find safety and performance information as covered in the Instructions for Use for the product: Surflo™ Winged Infusion Set with Needle Protection

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