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Flex-Pusher II

by H. + H. Maslanka Chirurgische Instrumente GmbH 5 variants

Ref FPIIXV120120 (51FP100)

Active European Union

CE MDR

Valid until

9 Sep 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DQS Medizinprodukte GmbH and 1 more

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 Number1000225429 Date29 Sep 2026IssuedStatusActive expires 9 Sep 2031

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 1000225429 Active

    Quality management system EU MDR

    Notified body
    DQS Medizinprodukte GmbH 0297
    Issued
    29 Sep 2026
    Expires
    9 Sep 2031
  • D1038400072 Withdrawn

    Technical documentation EU MDR

    Notified body
    mdc medical device certification GmbH 0483
    Issued
    11 Apr 2023
    Expires
    10 Apr 2028
    Reason
    Transferred to other nb

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Flex-Pusher I and II
Model / Reference
FPIIXV120120 (51FP100)
Primary DI / UDI-DI
04251121100018
Basic UDI-DI
42511211TD08BP
EMDN Code
C99 Cardiocirculatory devices - other
Device Class
Class III
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005600

Other devices from H.+H. Maslanka Chirurgische Instrumente GmbH

See all devices from H.+H. Maslanka Chirurgische Instrumente GmbH →

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