Organization name

Philips Medical Systems Nederland B.V.

SRN

NL-MF-000001489

Manufacturer status

Active

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

• CW999

  Avoid using the system with patients who are pregnant or who may possibly be pregnant. However, the risk may be outweighed by the benefit of diagnosing or treating a serious condition. It is the responsibility of the personnel operating the system to make the decision. Avoid using the system in case of existing radiation injury (operator or patient).

Primary placement in Netherlands; available across 28 countries total.

Trade name

Azurion 3 M12

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.

00884838085275

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-00884838085275

Reference / catalog number

722063

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

Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 12-inch flat detector.

Additional information URL

https://www.philips.com/doc_library%20(Instructionforuse)

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.

• Z11030102STATIONARY ANGIOGRAPHY SYSTEMS FOR ANGIOGRAPHIC AND CARDIOLOGIC STUDIES

• Class IIb medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.