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RespiFinder® 2SMART

by PathoFinder B.V. Netherlands EUDAMED

Ref PF2600-2S

EMDN W0105010118,W0105010503,W0105010803,W0105011607,W0105040501,W0105040502,W0105040504,W0105040505,W0105040517,W0105040518,W0105040519,W0105040520

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08719327116197 Basic UDI-DIDate14 Jun 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
PF2600-2S
Primary DI / UDI-DI
08719327116197
Basic UDI-DI
B-08719327116197
EMDN Code
W0105010118,W0105010503,W0105010803,W0105011607,W0105040501,W0105040502,W0105040504,W0105040505,W0105040517,W0105040518,W0105040519,W0105040520
Device Class
Class IVD Annex II List B
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000002704

From the manufacturer

Manufacturer's product page: 2SmartFinder® technologySingle tube Multiplex Amplification in Real Time

Other devices from PathoFinder B.V.

See all devices from PathoFinder B.V. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 7f219e2a-a9fa-4146-a51a-231a8d6c16c9 61 fields · synced 22 Oct 2026