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Ematik Lab

by PROMETHEUS S.r.l. Italy EUDAMED

Ref EL-01Model TD-01.01

EMDN B06

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805689325TD01HJ 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

Device Name
Ematik Lab
Model / Reference
TD-01.01, EL-01
Primary DI / UDI-DI
08056893250017, 08056893250000
Basic UDI-DI
805689325TD01HJ
Direct Marketing DI
08056893250017
08056893250000
EMDN Code
B06 Cellular or biological manipulation devices
Device Class
Class IIa
Market of Registration
Ireland
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000028429

Other devices from PROMETHEUS S.r.l.

Properties & raw data

Show properties, registry sources and raw records
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

Sources (2)

  • EUDAMED c3c81e12-4bc6-41cb-b1b4-cac216754235 61 fields · synced 22 Oct 2026
  • EUDAMED 08056893250000|805689325TD01HJ 61 fields · synced 19 May 2026