Organization name

TERUMO EUROPE N.V.

SRN

BE-MF-000001434

Manufacturer status

Active

5 warnings recorded — scroll inside the panel to see all entries.

• CW001

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW265

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.

Primary placement in Belgium; available across 32 countries total.

Trade name

RADIFOCUS Introducer II

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

05413206026661

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

5413206TRICE

Reference / catalog number

RT-R40G07PQ

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• Sheath Inner Diameter — 4 MU170
• Sheath Length — 7 MU10
• Dilator Tip Minimal Inner Diameter — 0.65 MU50
• Sheath Tip Minimal Inner Diameter — 1.33 MU50
• Dilator Maximal Outer Diameter — 1.47 MU50
• Mini Guide Wire Maximal Outer Diameter — 0.64 MU50
• Mini Guide Wire Length — 45 MU10
• 20 Gauge / 0.9 millimetre (mm)
• 1 3/8 Inch / 35 millimetre (mm)

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• C0504ARTERIAL INTRODUCTION SETS

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.

Certificate health across this manufacturer's portfolio.