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sinus-SuperFlex-635

by optimed Medizinische Instrumente GmbH 152 variants

Ref 8608.7100Model Stent

Active European Union

CE MDR

Valid until

12 Aug 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DEKRA Certification GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4047199SINSF63596 Basic UDI-DI 04047199503000UDI-DIDate13 Oct 2026RegisteredStatusActive

Certificates

2 certificates · EUDAMED

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

    Quality management system EU MDR

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

    Technical documentation EU MDR

    Certifier
    DEKRA Certification GmbH 0124
    Issued
    13 Aug 2026
    Expires
    12 Aug 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Stent, 8608.7100
Primary DI / UDI-DI
04047199503000
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