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Easy On-Off Fistula Set M

by Su Biyomedikal Sistemler ve Sağlık Hizmetleri Sanayi ve Ticaret Anonim Şirketi

Ref F00013469Model SET 5

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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/MDD NumberB-08684382950973 Basic UDI-DI 08684382950973UDI-DIDate16 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
SET 5, F00013469
Primary DI / UDI-DI
08684382950973
Basic UDI-DI
B-08684382950973
EMDN Code
F0399 Dialysis kits - other
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
TR-MF-000017528

Other devices from Su Biyomedikal Sistemler ve Sağlık Hizmetleri Sanayi ve Ticaret Anonim Şirketi

See all devices from Su Biyomedikal Sistemler ve Sağlık Hizmetleri Sanayi ve Ticaret Anonim Şirketi →

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