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A.V. Fistula Needle Set

by Jms Healthcare Phl, Inc 13 variants

Ref F00012252

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04806538160379 Basic UDI-DI 04806538160379UDI-DIDate20 Jul 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  • Withdrawn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

Device Name
A.V. Fistula Needle Set
Model / Reference
F00012252
Primary DI / UDI-DI
04806538160379
Basic UDI-DI
B-04806538160379
EMDN Code
F020101 Arteriovenous dialysis lines, one needle
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
PH-MF-000024060
Authorised representative
Bionic Medizintechnik GmbH DE-AR-000012049

Other devices from Jms Healthcare Phl, Inc

See all devices from Jms Healthcare Phl, Inc →

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