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Samson

by HumanTech Spine GmbH 58 variants

Ref 2000012738

Active European Union

CE MDR

Valid until

11 Feb 2031

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 Number42505399018N2 Basic UDI-DI 04250539915924UDI-DIDate15 Sep 2026RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 1000326828 Active

    Technical documentation EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    27 Aug 2026
    Expires
    26 Aug 2031
  • 1000326894 Active Supplemented

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    27 Aug 2026
    Expires
    11 Feb 2031
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
SA Vbr
Model / Reference
2000012738
Primary DI / UDI-DI
04250539915924
Basic UDI-DI
42505399018N2
EMDN Code
P09070302 Thoracolumbosacral fixation systems
Device Class
Class III
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000010596

Other devices from HumanTech Spine GmbH

  • VENUSnano

    Class IIb
  • Venus

    Class IIb
  • Samson

    Class III
  • Venus

    Class IIb
  • VENUSnano

    Class IIb
  • Samson

    Class III

See all devices from HumanTech Spine GmbH →

Properties

  • Implantable

Other properties (12)

  • Sterile: 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