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Falcon HST Nexus 360 Semi-Disposable Study Kit

by Compumedics Limited

Ref 7036-0029-00

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number9342451-8036-Kit-QR Basic UDI-DI 09342451006752UDI-DIDate31 Aug 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Falcon Kit
Model / Reference
7036-0029-00
Primary DI / UDI-DI
09342451006752
Basic UDI-DI
9342451-8036-Kit-QR
EMDN Code
Z12100585 Polysomnography instruments - consumables
Device Class
Class IIa
Medical Purpose
Consumables compatible with Falcon HST.

Manufacturer details

EUDAMED SRN
AU-PR-000057864

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Properties

Other properties (1)

  • Sterile: No