Skip to content

Trenza

by Stryker Neurovascular 7 variants

Ref IST00E0815Model 08858250000268RX

Active European Union

CE MDR

Valid until

24 Jun 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08858250000268RX Basic UDI-DI 07613327469509UDI-DIDate21 Sep 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 829526 Active

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    25 Jun 2026
    Expires
    24 Jun 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Trenza Embolization Device
Model / Reference
08858250000268RX, IST00E0815
Primary DI / UDI-DI
07613327469509
Basic UDI-DI
08858250000268RX
EMDN Code
C010404020201 Neurovascular embolisation coils
Device Class
Class III
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000002456
Authorised representative
Stryker European Operations Limited IE-AR-000000092

Other devices from Stryker Neurovascular

  • Wingspan

    Class III

  • AXS Catalyst 6

    Class III

  • AXS Catalyst 5

    Class III

  • AXS Catalyst 7

    Class III

  • Trenza

    Class III

  • AXS Infinity LS

    Class III

See all devices from Stryker Neurovascular →

Properties

  • Sterile
  • Implantable

Other properties (11)

  • 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