Organization name

Philips Ultrasound LLC

SRN

US-MF-000002237

Manufacturer status

Active

Primary placement in Germany; available across 32 countries total.

Trade name

QLAB Quantification System

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.

00884838122277

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.

0884838BM434SX

Reference / catalog number

795041

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

View and quantify image data acquired on Philips Ultrasound system

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.

• Z110603PICTURE ARCHIVING AND COMMUNICATION SYSTEMS

• Class IIa medical devices in EUDAMED

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