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Falcon HST Basic Disposable Study Kit

by Compumedics Limited

Ref 7036-0028-00

Falcon HST Basic Disposable Study Kit (7036-0028-00) is a Class IIa device made by Compumedics Limited, registered in EUDAMED on 31 Aug 2026 (Basic UDI-DI 9342451-8036-Kit-QR), active as of 25 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number9342451-8036-Kit-QR Basic UDI-DI 09342451007100UDI-DIDate31 Aug 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Falcon Kit
Model / reference
7036-0028-00
Primary DI / UDI-DI
09342451007100
Basic UDI-DI
9342451-8036-Kit-QR
EMDN code
Z12100585 Polysomnography instruments - consumables
Device class
Class IIa
System or procedure pack
System
EU registration type
System or procedure pack
Medical purpose
Consumables compatible with Falcon HST.

Manufacturer details

EUDAMED SRN
AU-PR-000057864

Other devices from Compumedics Limited

See all devices from Compumedics Limited →

Properties

Other properties (2, all answered No)