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Sterile cannula

by Alpha Omega Engineering Ltd

Ref STR-PS5135-00

Active European Union

CE MDR

Valid until

16 Nov 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number1000178902 Date1 Aug 2024IssuedStatusActive expires 16 Nov 2028

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 1000178902 Active Supplemented

    Technical documentation EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    1 Aug 2024
    Expires
    16 Nov 2028
    Reason
    Change approved
  • 1000324069 Active Supplemented Removed from EUDAMED

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    30 Jul 2026
    Expires
    5 Apr 2028
    Reason
    Change approved

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Cannulas and NeuroProbe
Model / Reference
STR-PS5135-00
Primary DI / UDI-DI
07290114063425
Basic UDI-DI
729011406123DISHA
EMDN Code
N010199 Neurophysiology devices - other
Device Class
Class III
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
IL-MF-000025214
Authorised representative
Alpha Omega GmbH DE-AR-000022420

Other devices from Alpha Omega Engineering Ltd

See all devices from Alpha Omega Engineering Ltd →

Properties

  • Sterile
  • Measuring Function

Other properties (11)

  • 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