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Pressure Monitor

by Spiegelberg GmbH & Co. KG

Ref MON.1.00.01Model MON.1.ST

Active European Union

CE MDR

Valid until

20 Mar 2029

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426012571MON1ST4Q Basic UDI-DI 04260125713841UDI-DIDate8 Jan 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000265927 Active

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    23 Oct 2025
    Expires
    20 Mar 2029

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
MON.1.ST, MON.1.00.01
Primary DI / UDI-DI
04260125713841
Basic UDI-DI
426012571MON1ST4Q
EMDN Code
Z12039001 Intracranial pressure measuring systems
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000000008

Other devices from Spiegelberg GmbH & Co. KG

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Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No