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sinus-SuperFlex-635

by optimed Medizinische Instrumente GmbH EUDAMED 152 variants

Active European Union

Ref 8608.7040Model Stent

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4047199SINSF63596 Basic UDI-DIDate13 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 50066-60-00-00 Active

    Quality management system EU MDR

    Notified body
    DEKRA Certification GmbH 0124
    Issued
    13 Aug 2026
    Expires
    12 Aug 2031
  • 50066-61-A0-00 Active

    Technical documentation EU MDR

    Notified body
    DEKRA Certification GmbH 0124
    Issued
    13 Aug 2026
    Expires
    12 Aug 2031

Specification

EUDAMED

Model / Reference
Stent, 8608.7040
Primary DI / UDI-DI
04047199502973
Basic UDI-DI
4047199SINSF63596
EMDN Code
P070402020102 Non-stainless steel peripheral vascular bare metal stents
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000021679

From the manufacturer

Manufacturer's product page: sinus-SuperFlex-635

Other devices from optimed Medizinische Instrumente GmbH

See all devices from optimed Medizinische Instrumente GmbH →

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