Organization name

Genome Diagnostics B.V.

SRN

NL-MF-000000453

Manufacturer status

Active

D-48499514C

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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

• Consult instructions for use

  Consult instructions for use before use

Primary placement in Netherlands; available across 32 countries total.

Trade name

KMRengine® Standard Entry (1 year)

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.

D-48499514C

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.

B-48499514C

Reference / catalog number

4849951

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.

EUDAMED

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

KMRengine is a quantitative software product intended to: 1) determine informative markers for recipient and donor(s), and 2) monitor the chimeric status over time, to drive clinical management. KMRengine is intended to be used for transplantation monitoring, which can be a critical healthcare situation or condition. KMRengine is intended for in silico diagnostic use by professional health care personnel, such as laboratory technicians and physicians, trained in chimerism testing in diagnostic laboratories.

Additional information URL

https://www.gendx.com/ifu2/

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.

• W02050192NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE

• IVDD — General medical devices in EUDAMED

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