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Arterial Venous Fistula Set

by Sb-Kawasumi Laboratories, Inc. 86 variants

Ref GF-6218E

Active European Union

CE MDR

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4987488AVF_F9 Basic UDI-DI 04987488097639UDI-DIDate22 Jul 2025RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Model / Reference
GF-6218E
Primary DI / UDI-DI
04987488097639
Basic UDI-DI
4987488AVF_F9
EMDN Code
A010401 Arteriovenous fistula needles
Device Class
Class IIa
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
JP-MF-000011253
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Sb-Kawasumi Laboratories, Inc.

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Properties

  • Sterile
  • CMR Substance
  • Endocrine Disruptor

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No