Organization name

Hain Lifescience GmbH

SRN

DE-MF-000008606

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW082

  EUDAMED did not publish a description for this code.
• CW085

  EUDAMED did not publish a description for this code.
• CW167

  EUDAMED did not publish a description for this code.
• CW397

  EUDAMED did not publish a description for this code.
• CW416

  EUDAMED did not publish a description for this code.
• CW311

  EUDAMED did not publish a description for this code.
• CW132

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 32 countries total.

Trade name

GenoType MTHFR VER 3.0

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.

04049055000364

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-04049055000364

Reference / catalog number

252

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.

IVDD — General

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The GenoType MTHFR VER 3.0 is a qualitative in vitro test for the combined characterization of positions 677 and 1298 of the human methylenetetrahydro-folate reductase (MTHFR) gene from whole blood samples. The test is indicated as an aid for diagnosis and intended for use in medical laboratories.

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.

• W0106010116OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)

• IVDD — General medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.