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PATHFAST NTproBNP

by PHC Corporation

Ref 30161

PATHFAST NTproBNP (30161) is an in vitro diagnostic device (EU IVDR Class C; EMDN category bnp / probnp (including other natriuric peptides)) made by Phc Corporation, registered in EUDAMED on 27 May 2026 (Basic UDI-DI 4987595PF1061KXK) with CE/IVDR certificate V76 123901 0007 valid until 28 Feb 2028, active as of 7 Nov 2026.

Active European Union

CE IVDR

Valid until

28 Feb 2028

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberV76 123901 0007 Date5 Jun 2026IssuedStatusActive expires 28 Feb 2028

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Timeline

3 dated events

  1. Registered EUDAMED 4987595PF1061KXK
  2. Certificate issued EUDAMED V76 123901 0007
  3. Certificate expires EUDAMED V76 123901 0007

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / reference
30161
Primary DI / UDI-DI
04987595301612
Basic UDI-DI
4987595PF1061KXK
EMDN code
W01021301 Bnp / probnp (including other natriuric peptides)
Device class
Class C
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
JP-MF-000008516
Authorised representative
PHC Europe B.V. NL-AR-000002692

Similar devices in this category

Other devices filed under BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES).

Other devices from Phc Corporation

See all devices from Phc Corporation →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Near-patient testing
  • Professional testing
Other properties (6, all answered No)