Organization name

InSightec Ltd.

SRN

IL-MF-000011795

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• Consult instructions for use

  Refer to instruction manual/ booklet

Primary placement in Germany; available across 16 countries total.

Trade name

Head Frame Set for Exablate 4000 Type 1.1 Systems

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.

07290019402701

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.

7290015461Ex4000-PPTX

Reference / catalog number

SET400168-CA-CE

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 IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Head Frame Set for Exablate 4000 Type 1.1 Systems (PFK)

Additional information URL

No additional information URL provided by the manufacturer.

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.

• Z120610ULTRASOUND THERAPY EQUIPMENT

• Class IIb medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.