LumiGuide Equipment Upgrade

Organization name

Philips Medical Systems Nederland B.V.

SRN

NL-MF-000001489

Manufacturer status

Active

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

• CW274

  EUDAMED did not publish a description for this code.
• CW018

  EUDAMED did not publish a description for this code.

Primary placement in Netherlands; available across 10 countries total.

Trade name

LumiGuide Equipment Upgrade

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.

00884838129474

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.

0884838BM1700MC

Reference / catalog number

722485

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

Upgrade for LumiGuide Equipment: visualization device with FORS technology intended to aid the positioning and navigation of a connected LumiGuide Wire, and optionally a catheter, during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a real-time 3D visualization of a connected LumiGuide Wire, and optionally a catheter when combined with a LumiGuide 3D Hub.

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.

• Z11039099VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER

• Class IIb medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.