Organization name

Philips Medical Systems Nederland B.V.

SRN

NL-MF-000001489

Manufacturer status

Active

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

Primary placement in Netherlands; available across 32 countries total.

Trade name

SmartPath to Ingenia Elition X

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.

00884838115743

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.

0884838BM697TZ

Reference / catalog number

782163

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 to the Elition X for our customers having an Ingenia 3.0T

Additional information URL

https://www.philips.nl/healthcare/over-ons/support/resource-center/results#sort=relevancy&f:@ps_contenttype=[Instruction%20for%20Use]&f:@ps_modality=[Magnetic%20resonance%20(MRI)]&f:@ps_language=[English%20(US)]

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.

• Z11050105CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 2T AND LESS THAN OR EQUAL TO 4T

• Class IIb medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.