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Internal Standard Mix

by Chromsystems Instruments + Chemicals GmbH 3 variants

Ref 80604/5

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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/IVDR Number4250317806006A Basic UDI-DI 04250317537478UDI-DIDate17 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
MassChrom® Biogenic Amines / Metabolites in Urine Sample Prep Set Catecholamines, free Metanephrines, Serotonin
Model / Reference
80604/5
Primary DI / UDI-DI
04250317537478
Basic UDI-DI
4250317806006A
EMDN Code
W0101050399 Calibrators and standards (clinical chemistry) - other
Device Class
Class C
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000010089

Other devices from Chromsystems Instruments & Chemicals GmbH

See all devices from Chromsystems Instruments & Chemicals GmbH →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

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