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DONA SENSIplus

by VULKAN - Medical, a.s. EUDAMED

Active European Union

Ref 9012-L-E

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number859420032LAT2EM Basic UDI-DIDate15 Jan 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  • Withdrawn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
Rukavice latexové vyšetřovací, bezprašné
Model / Reference
9012-L-E
Primary DI / UDI-DI
08594200323202
Basic UDI-DI
859420032LAT2EM
EMDN Code
T010201 Latex examination / treatment gloves
Device Class
Class I
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000016349

Other devices from VULKAN - Medical, a.s.

See all devices from VULKAN - Medical, a.s. →

Properties

  • Contains Latex

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: 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