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Bionic Fistula Needle

by Jms Healthcare Phl, Inc Philippines EUDAMED

Ref 340-AGAM EMDN F020101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number480653816001CK Basic UDI-DIDate29 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
A.V. Fistula Needle Set
Model / Reference
340-AGAM
Primary DI / UDI-DI
04806538161468
Basic UDI-DI
480653816001CK
EMDN Code
F020101 Arteriovenous dialysis lines, one needle
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

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

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See all devices from Jms Healthcare Phl, Inc →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 04806538161468|480653816001CK 61 fields · synced 25 Oct 2026