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activeDrive

by Active Medical Xcellence GmbH

Ref 1000002Model activeCut

Active European Union

CE MDR

Valid until

15 Dec 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SLG PRÜF UND ZERTIFIZIERUNGS GMBH

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/MDR Number111178U2 Date7 May 2026IssuedStatusActive expires 15 Dec 2030

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 111178U2 Active Supplemented

    Quality management system EU MDR

    Issued
    7 May 2026
    Expires
    15 Dec 2030
    Reason
    Change approved

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Morcellator activeCut
Model / Reference
activeCut, 1000002
Primary DI / UDI-DI
04069019000018
Basic UDI-DI
4069019activeCut001VB
Direct Marketing DI
04069019000018
EMDN Code
U0999 Urogenital endoscopic devices - other
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000049306

Other devices from Active Medical Xcellence GmbH

Properties

Other properties (13)

  • Sterile: No
  • 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