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Slender

by Shunmei Medical Co., Ltd 7 variants

Ref 635752

Active European Union

CE MDR

Valid until

10 Mar 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi

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 Number69560144GECZF Basic UDI-DI 06956014457528UDI-DIDate17 Mar 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1TD-MDR-0061/03/2026/03 Active

    Technical documentation EU MDR

    Certifier
    Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi 2764
    Issued
    11 Mar 2026
    Expires
    10 Mar 2029

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Guiding Extention Catheter
Model / Reference
635752
Primary DI / UDI-DI
06956014457528
Basic UDI-DI
69560144GECZF
EMDN Code
C0104010202, C0104020204
Device Class
Class III
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000001160
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shunmei Medical Co., Ltd

See all devices from Shunmei Medical Co., Ltd →

Properties

  • Sterile

Other properties (12)

  • Implantable: 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