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ATLAS Neurophysiology System

by FHC Inc. EUDAMED

Active European Union

Ref 31-0605-0168

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08677180002.10-100-1-A.NC Basic UDI-DIDate14 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Model / Reference
31-0605-0168
Primary DI / UDI-DI
00860016269323
Basic UDI-DI
08677180002.10-100-1-A.NC
EMDN Code
Z12100380 Electroencephalography instruments - hardware accessories
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
US-MF-000012111
Authorised representative
TERMOBIT PROD SRL RO-AR-000010668

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Properties

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