Medi-Test Combi 5S

Organization name

MACHEREY-NAGEL GmbH & Co. KG

SRN

DE-MF-000005636

Manufacturer status

Active

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

• CW009

  EUDAMED did not publish a description for this code.
• CW018

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 11 countries total.

Trade name

Medi-Test Combi 5S

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.

04046681000201

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.

4046681151040VR

Reference / catalog number

93055

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 B

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Test strips for urine analysis

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.

• W0101060201URINE SINGLE TEST STRIPS (INCL. TABLETS)

• IVDR Class B medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.