Organization name

Farapulse Inc

SRN

US-MF-000017969

Manufacturer status

Active

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

• CW018

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.

Primary placement in Netherlands; available across 32 countries total.

Trade name

FARAWAVE™

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.

00810087180102

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.

B-00810087180102

Reference / catalog number

41M402

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 III

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

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

Clinical sizes

• 35 MU50

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

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

• C020304ARRHYTHMOGENIC FOCI PULSED FIELD ABLATION CATHETERS

• Class III medical devices in EUDAMED

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