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Softly 8

by de Götzen S.r.l. Italy EUDAMED

Ref 6.01.00103, 6.01.00111Model Amalgamator

EMDN Z12119002

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++D804601KE Basic UDI-DIDate31 May 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
Softly 8
Softly
Model / Reference
Amalgamator, 6.01.00103, 6.01.00111
Primary DI / UDI-DI
+D804601001030Y, *+D804601001110X*
Basic UDI-DI
++D804601KE
Direct Marketing DI
+D804601001030Y
EMDN Code
Z12119002 Amalgamators
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000013302

Other devices from de Götzen S.r.l.

See all devices from de Götzen 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 a0f1d948-7b4e-45ac-8f5c-8aa265bb6fbd 61 fields · synced 22 Oct 2026
  • EUDAMED *+D804601001110X*|++D804601KE 61 fields · synced 8 Jul 2026