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Smart Care

by Delta Care for Medical Industries Co, Ltd. EUDAMED 4 variants

Active European Union EUDAMED: not on the EU market

Ref SC101

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number622301829FIAM64 Basic UDI-DIDate22 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Fluorescent Immunoassay Analyzer
Model / Reference
SC101
Primary DI / UDI-DI
06223018290315
Basic UDI-DI
622301829FIAM64
Direct Marketing DI
06223018290315
EMDN Code
W0201020201 Immunochemistry readers
Device Class
Class A

Manufacturer details

EUDAMED SRN
EG-MF-000044132
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

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