PATHFAST D-Dimer

Organization name

PHC Corporation

SRN

JP-MF-000008516

Manufacturer status

Active

Primary placement in Netherlands; available across 12 countries total.

Trade name

PATHFAST D-Dimer

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.

04987595301513

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.

4987595PF1051KXE

Reference / catalog number

30151

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

Non-sterile

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.

• W0103020503D-DIMER

• IVDR Class C medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.