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Neptune

by Orbit Health GmbH Germany EUDAMED

Ref 00001

EMDN Z12040182

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426075677Neptune00001N3 Basic UDI-DIDate19 Jan 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

Model / Reference
00001
Primary DI / UDI-DI
04260756770053, 04260756770046
Basic UDI-DI
426075677Neptune00001N3
Direct Marketing DI
04260756770053
04260756770046
EMDN Code
Z12040182 General medicine diagnosis and monitoring instruments - software accessories
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000014327

Other devices from Orbit Health GmbH

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 cd2c29c8-c95d-4671-841d-768a0fb5eeb5 61 fields · synced 22 Oct 2026
  • EUDAMED 04260756770046|426075677NEPTUNE00001N3 61 fields · synced 19 May 2026