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Aspiflex

by Meika Group S.r.l. 78 variants

Ref ASP2030Model ASPIFLEX

Active European Union

CE MDR

Valid until

9 Sep 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier ICIM S.P.A.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805534843FT04ASPCY Basic UDI-DI 08055348433739UDI-DIDate12 Sep 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030144-00 Active

    Quality management system EU MDR

    Certifier
    ICIM S.P.A. 0425
    Issued
    10 Sep 2025
    Expires
    9 Sep 2030

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Aspiflex
Model / Reference
ASPIFLEX, ASP2030
Primary DI / UDI-DI
08055348433739
Basic UDI-DI
805534843FT04ASPCY
EMDN Code
K01020199 Minimally invasive surgery surgical instrument kits, single-use - other
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000029106

Other devices from Meika Group S.r.l.

See all devices from Meika Group S.r.l. →

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No