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Centrifuges for Cell Processing

by Miracell Co., Ltd.

Ref SMART M-CELLModel SMART M-CELL 2, SMART M-CELL 4, SMART M-CELL 4-A

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number88089008MR00I09MN Basic UDI-DI 08809286200591UDI-DIDate30 Sep 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
Centrifuges for Cell Processing
Model / Reference
SMART M-CELL 2, SMART M-CELL 4, SMART M-CELL 4-A, SMART M-CELL
Primary DI / UDI-DI
08809286200591
Basic UDI-DI
88089008MR00I09MN
EMDN Code
W02069003 Centrifuges
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
KR-MF-000026346
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Properties

Other properties (11)

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