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DORA Disposable A.V. Fistula Needle Sets

by Bain Medical Equipment(Guangzhou)Co., Ltd. EUDAMED

Active European Union

Ref BAIN-A.V.F-034VEModel AVF-BR2515BE-15, AVF-BR2515BE-16, AVF-BR2515E-15, AVF-BR2515E-16

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69480827021329Y Basic UDI-DIDate26 Jan 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  • Withdrawn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

Device Name
Disposable A.V. Fistula Needle Sets
Model / Reference
AVF-BR2515BE-15, AVF-BR2515BE-16, AVF-BR2515E-15, AVF-BR2515E-16, BAIN-A.V.F-034VE
Primary DI / UDI-DI
06948082773310
Basic UDI-DI
69480827021329Y
EMDN Code
A010401 Arteriovenous fistula needles
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000005196
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Bain Medical Equipment(Guangzhou)Co., Ltd.

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Properties

  • Sterile
  • CMR Substance

Other properties (11)

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