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MAS Omni•CARDIO Control Max, Level 3

by Microgenics Corporation United States EUDAMED

Ref OCRDM-303Model OCRDM-UL EMDN W0101050299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0884883MCDDFRREC230706R Basic UDI-DIDate14 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
MAS Omni•CARDIO Control Max, Level Ultra Low
Model / Reference
OCRDM-UL, OCRDM-303
Primary DI / UDI-DI
00884883009615
Basic UDI-DI
0884883MCDDFRREC230706R
EMDN Code
W0101050299 Specific controls (cc) - other
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000030375
Authorised representative
B·R·A·H·M·S GmbH DE-AR-000026031

Other devices from Microgenics Corporation

See all devices from Microgenics Corporation →

Properties & raw data

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

Sources (1)

  • EUDAMED 00884883009615|0884883MCDDFRREC230706R 61 fields · synced 24 Oct 2026