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Som-100

by Belmont Diagnostics France EUDAMED

Ref SOM100-002Model SOM-100

EMDN W02079085

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number3770035090SOM100Z8 Basic UDI-DIDate4 Sep 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Som-100
Model / Reference
SOM-100, SOM100-002
Primary DI / UDI-DI
03770035090013
Basic UDI-DI
3770035090SOM100Z8
Unit of Use DI
03770035090006
EMDN Code
W02079085 Various general purpose IVD instruments - consumables
Device Class
Class A
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000043467

Properties & raw data

Show properties, registry sources and raw records
  • New Device
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 5663a9a1-27e4-4f80-ae3d-42f74a8e2971 61 fields · synced 22 Oct 2026