7611

Organization name

AmplexDiagnostics GmbH

SRN

DE-MF-000014117

Manufacturer status

Active

Primary placement in Germany; available across 14 countries total.

Trade name

not provided

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.

04250592376113

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.

4250592376119N

Reference / catalog number

7611

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

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.

IVDR Class C

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

eazyplex® MRSAplus is a manual in vitro diagnostic medical device for the qualitative detection of specific nucleic acid sequences (DNA) of MRSA (methicillin-resistant Staphylococcus aureus) and the Panton-Valentine Leukocidin gene (PVL) by means of LAMP technique ("loop-mediated isothermal amplification")

Additional information URL

No additional information URL provided by the manufacturer.

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.

• W0104080602NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED MRSA AND/OR MSSA

• IVDR Class C medical devices in EUDAMED

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