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JMS SysLoc Safety A.V. Fistula Needle Set

by JMS Singapore Pte Ltd EUDAMED

Active European Union

Ref 862-1511

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-862-1511AA Basic UDI-DIDate7 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Sysloc Avf
Model / Reference
862-1511
Primary DI / UDI-DI
D-862-1511AA
Basic UDI-DI
B-862-1511AA
EMDN Code
A010401 Arteriovenous fistula needles
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
SG-MF-000024704
Authorised representative
Bionic Medizintechnik GmbH DE-AR-000012049

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Properties

  • Sterile

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