Organization name

Biosense Webster, Inc

SRN

US-MF-000014219

Manufacturer status

Active

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

• Caution
• Consult instructions for use
• Do not use if package is damaged
• Do not use if package is opened

  OTHER

Primary placement in Belgium; available across 32 countries total.

Trade name

SMARTABLATE System Interface Cable

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.

10846835012644

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.

08468350a0003ET

Reference / catalog number

D130303

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 I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Interface Cable For use with BWI therapeutic catheter and the SMARTABLATE System

Additional information URL

https://www.e-ifu.com/

Clinical sizes

No clinical sizes registered for this device.

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

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

• Z12059080VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - HARDWARE ACCESSORIES

• Class I medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.