Organization name

MACHEREY-NAGEL GmbH & Co. KG

SRN

DE-MF-000005636

Manufacturer status

Active

15 warnings recorded — scroll inside the panel to see all entries.

• Refer to instruction manual/booklet
• GHS02 - Danger or Warning - Flammable
• GHS07 - Warning -Toxic cat. 4, Irritant cat. 2 or 3, Lower systemic health hazards
• GHS08 - Danger or Warning - Systemic health hazards
• H226 – Flammable liquid and vapour.
• H302 – Harmful if swallowed.
• H315 – Causes skin irritation.
• H319 – Causes serious eye irritation.
• H334 – May cause allergy or asthma symptoms or breathing difficulties if inhaled.
• H412 – Harmful to aquatic life with long lasting effects.
• P210 – Keep away from heat/sparks/open flames/hot surfaces. — No smoking.
• P261 – Avoid breathing dust/fume/gas/mist/vapours/spray.
• P264 – Wash thoroughly after handling.
• P301 – IF SWALLOWED: P312 – Call a POISON CENTER or doctor/physician if you feel unwell.
• P342 – If experiencing respiratory symptoms: P311 – Call a POISON CENTER or doctor/physician.

Primary placement in Germany; available across 12 countries total.

Trade name

NucleoMag® Dx Pathogen

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.

04046681154539

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.

4046681151019W2

Reference / catalog number

744215.4

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 A

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Kit for isolation of viral nucleic acids

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.

• W0105900101REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

• IVDR Class A medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.