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Disposable AV Fistula Needle Sets

by Vital Healthcare Sdn. Bhd. 87 variants

Ref AVF2016LR01G

Active European Union

CE MDR 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-09551019766308 Basic UDI-DI 09551019766308UDI-DIDate14 May 2026RegisteredStatusActive
European UnionCE/MDD NumberB-09551019766308 Basic UDI-DI 09551019766308UDI-DIDate14 May 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  • Withdrawn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/MDR, CE/MDD Active

Specification

EUDAMED

Model / Reference
AVF2016LR01G
Primary DI / UDI-DI
09551019766308
Basic UDI-DI
B-09551019766308, 9555793100223325
EMDN Code
A010401 Arteriovenous fistula needles
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
MY-MF-000005704
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Vital Healthcare Sdn. Bhd.

See all devices from Vital Healthcare Sdn. Bhd. →

Properties

  • 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