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NORSAN Fettsäure-Analyse

by NORSAN GmbH

Ref 5034

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberPP073721351272401 Basic UDI-DI Date21 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
5034
Primary DI / UDI-DI
111351272426, 04260698152252
Basic UDI-DI
PP073721351272401, 4260698155034ZW
EMDN Code
W0501010299, W0501010201
Device Class
Class I
Class A
EU market of registration
Germany
Medical Purpose
Das System ist spezifisch dafür bestimmt, die sichere Entnahme, den Schutz, die Stabilisierung sowie den Transport von humanem kapillarem Blut aus der Fingerbeere zu gewährleisten. Es erhält die Integrität der Fettsäuren in den roten Blutkörperchen während des Transports vom Entnahmeort zum qualifizierten Fachlabor aufrecht. Die gewonnenen Proben sind zur laborseitigen, quantitativen Bestimmung des Omega-3-Index mittels einer validierten wissenschaftlich-analytischen Methode vorgesehen.

Manufacturer details

EUDAMED SRN
DE-PR-000057202

Properties

  • Professional Testing

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No