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Sirius Pintuition Seed 20cm

by Sirius Medical Systems B.V.

Ref SPS20

Active European Union

CE MDR

Valid until

1 Dec 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DEKRA Certification B.V.

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 Number8719992742PINTUITIONY9 Basic UDI-DI 08719992742929UDI-DIDate28 May 2026RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2261039CE01 Active

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    19 Dec 2025
    Expires
    1 Dec 2030
  • 2261039TD01 Active Supplemented

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    25 Apr 2026
    Expires
    1 Dec 2030
    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  • Withdrawn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
Sirius Pintuition Localization System
Model / Reference
SPS20
Primary DI / UDI-DI
08719992742929
Basic UDI-DI
8719992742PINTUITIONY9
EMDN Code
A019012 Breast nodules and other structures localisation needles and systems
Device Class
Class IIb
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000010932

Other devices from Sirius Medical Systems B.V.

Properties

  • Sterile
  • Implantable

Other properties (12)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: 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