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B-Aura

by Tedisel Iberica S.L. EUDAMED

Active European Union

Ref B-AURAModel BASIC-SC

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number84370247BASICSCMC Basic UDI-DIDate25 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Basic-Sc
Model / Reference
BASIC-SC, B-AURA
Primary DI / UDI-DI
08437024708445
Basic UDI-DI
84370247BASICSCMC
Direct Marketing DI
08437024708445
EMDN Code
Z129017 Bed head units
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000026074

Other devices from Tedisel Iberica S.L.

See all devices from Tedisel Iberica S.L. →

Properties

Other properties (13)

  • Sterile: No
  • 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