# PATHFAST D-Dimer

> Active: European Union. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/pathfast-d-dimer-30151>
- Manufacturer: [PHC Corporation](https://devicerts.com/manufacturers/phc-corporation) (Japan)
- Device class: Class C (EU IVDR)
- EMDN: W0103020503 D-DIMER

## Registrations and authorizations

- **EUDAMED** · CE/IVDR · European Union · V76 123901 0007 · issued 2026-06-05 · expires 2028-02-28 · status: Active
- **EUDAMED** · CE/IVDR · European Union · Basic UDI-DI 4987595PF1051KXE · UDI-DI 04987595301513 · registered 2026-05-27 · status: Active

## EU certificates

- V76 123901 0007 · Technical documentation · IVDR · notified body TÜV SÜD Product Service GmbH · issued 2026-06-05 · expires 2028-02-28 · status: issued

## Recalls

No recall on record.

## EU market availability

- Czechia
- France
- Germany
- Greece
- Hungary
- Italy
- Lithuania
- Netherlands
- Poland
- Romania
- Slovenia
- Spain

## Identity

- Model / reference: 30151 [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 04987595301513 [EUDAMED]
- Basic UDI-DI: 4987595PF1051KXE [EUDAMED]
- EMDN code: W0103020503 [EUDAMED]

## Classification

- Device class: Class C [EUDAMED]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Netherlands [EUDAMED]

## Properties

- Contains human tissues or cells: Yes [EUDAMED]
- Contains animal tissues or cells: Yes [EUDAMED]
- Reagent: Yes [EUDAMED]
- IVD kit: Yes [EUDAMED]
- Near-patient testing: Yes [EUDAMED]
- Professional testing: Yes [EUDAMED]
- Supplied sterile: No [EUDAMED]
- Sterilise before use: No [EUDAMED]
- Contains substances of microbial origin: No [EUDAMED]
- Self-testing: No [EUDAMED]
- Companion diagnostics: No [EUDAMED]
- IVD instrument: No [EUDAMED]
- New device: No [EUDAMED]

## Source and citation

- Cite as: PATHFAST D-Dimer, PHC Corporation. deviCERTS medical device catalogue. https://devicerts.com/devices/pathfast-d-dimer-30151 (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-11-07
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/pathfast-d-dimer-30151.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/pathfast-d-dimer-30151
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.