Organization name

Philips Medical Systems Nederland B.V.

SRN

NL-MF-000001489

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW999

  Fragile, handle with care
• CW999

  Keep dry
• CW999

  Keep away from sunlight
• CW999

  Single sterile barrier system
• CW999

  Single sterile barrier system with protective packaging inside

Primary placement in Netherlands; available across 17 countries total.

Trade name

LumiGuide 3D Hub

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.

00884838111141

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.

0884838BM853TP

Reference / catalog number

LGHN35

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 I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The LumiGuide 3D Hub enables the visualization of a connected endovascular catheter, when used in combination with a LumiGuide Wire and the LumiGuide Equipment.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 90 MU50
• 0.89 MU50

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

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

• Z11039085VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - CONSUMABLES

• Class I medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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