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11-0443-B

by Schölly Fiberoptic GmbH

Ref 11-0443-BModel Laparoscopes

Expiring European Union

CE MDR

Valid until

27 Apr 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number1000285837 Date15 Jan 2026IssuedStatusExpiring expires 27 Apr 2027

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000285837 Restricted

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    15 Jan 2026
    Expires
    27 Apr 2027
    Reason
    Not on market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Model / Reference
Laparoscopes, 11-0443-B
Primary DI / UDI-DI
04250480102619
Basic UDI-DI
42504801LAPAROSCOPESEF
Direct Marketing DI
04250480102619
EMDN Code
Z12029009 Laparoscopes
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005618

Other devices from SCHÖLLY FIBEROPTIC GmbH

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  • 11-0441-A

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  • 95-3985

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  • 11-0431-B

    Class IIa

See all devices from SCHÖLLY FIBEROPTIC 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