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.

• CW018

  EUDAMED did not publish a description for this code.

Primary placement in Netherlands; available across 31 countries total.

Trade name

BlueSeal SE

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.

00884838128415

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

782193

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

Excel in your daily MR services Based on its revolutionary fully sealed BlueSeal magnet, BlueSeal SE lets you experience more productive (1) helium-free MR operations. The BlueSeal SE delivers superb image quality with up to 80% sharper images(2) even for challenging patients, and performs MRI exams up to 3x faster (3) with SmartSpeed Precise accelerations for all anatomies. Fast overall exam time is achieved by simplifying patient handling at the bore with the guided patient setup. Furthermore, the BlueSeal SE offers an immersive audio visual experience to help calm patients and guide them through MR exams. 1 Compared to the Ingenia 1.5T ZBO magnet. 2 Compared to Philips SENSE/ C-SENSE imaging. 3 Compared to Philips SENSE imaging

Additional information URL

https://www.philips.com/doc_library

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
• Z11050104CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T

• Class IIb medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.