Product responsibilities in Regulatory Affairs (RA)

TERUMO INTERVENTIONAL SYSTEMS

Group 1 (PCI)
- Stents
Kaname, Ultimaster, Misago, Tsunami Gold, Tsunami peripheral, Roadsaver

- Balloons & related Guide Wires

Accuforce, Hiryu, Tazuna, Ryujin Plus, Ryujin Plus OTW, Tercross, RX Muso, Senri, Metacross RX,
Metacross OTW, Crosperio RX, Crosstella OTW; Crosswire, Crosswire NT, Muso Wire,
Runthrough NS, Runthrough NS Extension Wire

- Catheters
Eliminate, Navicross, Finecross MG, FineDuo

- Other devices
STARsystem, Nanoparasol, QuiremSpheres

= responsibility of Leen Callewaert supported by Ariane Vancle, focus of Leen is on stents and
QuiremSpheres. Focus of Ariane is on balloons and related guide wires, catheters, STARsystem and
Nanoparasol.

Group 2 (PCI)
- Active devices (Valrie)
OFDI (Fastview Catheter, MDU Cover, Lunawave), Iberis Renal Denervation System,
TATO MicroWave Ablation System

- Embolo & Oncolo (Sughis)

Azur Detachment Controlller, Azur Peripheral Coil System, LifePearl, HydroPearl, Progreat, Occlusafe

- Diagnostic Catheters & Wires, Guiding catheters, Introducers and accessories, Vascular Closure
Devices (Katryn)
Outlook, RF Angiographic Catheter, RF Glidecath, RF Optitorque, RF Glidewire Advantage (including
RF Glidewire Advantage Track), RF Guide GT, RF Guide Wire M, RF Guide Wire Non-Vascular,
Climber, Heartrail II, Destination, Glidesheath Slender, RF Introducer II, RF Introducer II
(transradial access), RF Introducer II with RO Marker, Solopath , RF Haemostasis Valve II,
RF Obturator, RF Torque Device, RF Vessel Dilator, TR Band, iVAC, Angio-Seal, FemoSeal

= responsibility of Valrie Boydens supported by Katryn Scheys and Muhammed Sughis, focus of Valrie
is on the active devices, Sughis on Embolo/Oncolo and Katryn on the remaining products of Group 2 .

CARDIOVASUCULAR SYSTEMS
= responsibility of Valrie Boydens with back up of Simona Beri and Muhammed Sughis.

MEDICAL PRODUCTS AND TERUMO PHARMACEUTICAL SOLUTIONS

Medical products = hospital and labo
= responsibility of Liesbeth Decoster supported by Natalia Crespo Biel

DIABETES SYSTEMS
= responsibility of Valrie Boydens supported by Liesbeth Decoster.

03-2017
Note:
- For registration requests of MP and TPS products, please send WRA-110A to Natalia Crespo-Biel, cc.
Liesbeth Decoster
- For registration requests of TIS products, please send WRA-110A to Sophie Rooms, cc. Simona Beri
- For registration requests of CV products, please send WRA-110A to Simona Beri, cc. Valrie Boydens
- For registration requests of DM products, please send WRA-110A to Valrie Boydens, cc. Natalia
Crespo-Biel