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Ematik Lab Kit

by PROMETHEUS S.r.l. Italy EUDAMED

Ref ELK-01

EMDN B06

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805689325TD02HL Basic UDI-DIDate19 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
ELK-01
Primary DI / UDI-DI
08056893250048, 08056893250055
Basic UDI-DI
805689325TD02HL
Direct Marketing DI
08056893250048
08056893250055
EMDN Code
B06 Cellular or biological manipulation devices
Device Class
Class IIa
Market of Registration
Italy
Ireland

Manufacturer details

EUDAMED SRN
IT-MF-000028429

Other devices from PROMETHEUS S.r.l.

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Contains Latex
Other properties (11)
  • 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

Sources (2)

  • EUDAMED 59d4432a-6cb7-4007-a085-df1cc4fba596 61 fields · synced 22 Oct 2026
  • EUDAMED 08056893250055|805689325TD02HL 61 fields · synced 19 May 2026