Gating Module PT

Organization name

DYN'R

SRN

FR-MF-000001876

Manufacturer status

Active

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

• Consult instructions for use
• Not to be disposed of household waste

  OTHER

• Caution

  OTHER

Primary placement in Austria; available across 11 countries total.

Trade name

Gating Module PT

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.

03760290230156

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-03760290230156

Reference / catalog number

SDX0367N

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

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

Status

On the market

Quantity

1

Additional product description

The SDX System and Gating Module is intended to be used in conjunction with a Radiation Therapy system (imaging & treatment) requiring operator intervention to start & stop radiation. The Gating Module is intended to facilitate the interface between operators, whilst ensuring at all times the operators have complete control & maintain the final decision in imaging & treatment. It provides the direct interface between the SDX System and the Imaging / Radiation Treatment equipment.

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.

• Z11019099VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER

• Class IIb medical devices in EUDAMED

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