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ClinMass® Add-on Set for Tricyclic Antidepressants in Serum / Plasma

by RECIPE Chemicals + Instruments GmbH

Ref MS9100

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4049195BMS91X0PL Basic UDI-DI 04049195006004UDI-DIDate27 Nov 2025RegisteredStatusActive

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  • Withdrawn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
TDM Tricyclic Antidepressants in Serum / Plasma
Model / Reference
MS9100
Primary DI / UDI-DI
04049195006004
Basic UDI-DI
4049195BMS91X0PL
Direct Marketing DI
04049195006004
EMDN Code
W01010499 Multiple clin. chem lab reagents - other
Device Class
Class B
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000032553

Other devices from RECIPE Chemicals + Instruments GmbH

See all devices from RECIPE Chemicals + Instruments 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