Organization name

Philips Ultrasound LLC

SRN

US-MF-000002237

Manufacturer status

Active

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

• MR UNSAFE

Primary placement in Germany; available across 32 countries total.

Trade name

Lumify Rugged System Bundle

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.

00884838108448

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.

0884838BM433SV

Reference / catalog number

795007

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 IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The Lumify Diagnostic Ultrasound System is a mobile, general purpose, software-controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. Lumify is a portable system facilitating point of care ultrasound applications. [EN]

Additional information URL

https://www.usa.philips.com/healthcare/support/resource-center/results?sort=relevancy&f:@ps_contenttype=%5bInstruction%20for%20Use%5d&f:@ps_language=%5bEnglish%20%28US%29%2cEnglish%5d&f:@ps_modality=%5bUltrasound%5d

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.

• Z1104018099ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER

• Class IIa medical devices in EUDAMED

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