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Falcon HST Assembly

by Compumedics Limited

Ref 8036-0002-02Model Falcon HST System EU

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number9342451FalconH9 Basic UDI-DI 09342451002747UDI-DIDate3 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09342451002747 UDI-DI Date12 Mar 2026ListedStatusListed GUDID: in commercial distribution

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Falcon HST Assembly EUDAMED
Compumedics Falcon GUDID
Generic Name
Polysomnograph
Device Name
Falcon HST
Model / Ref / Catalog
Falcon HST System EU, 8036-0002-02, Falcon HST
Primary DI / UDI-DI
09342451002747
Basic UDI-DI
9342451FalconH9
510(k) Number
FDA Product Code
MNR, OLV, OMC
EMDN Code
Z12100501 Polysomnographs
GMDN Term
Polysomnograph
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.2375, 882.1400
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Falcon HST System EU
8036-0002-02
GUDID
Falcon HST
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
AU-MF-000050437
Authorised representative
Compumedics EUROPE GmbH DE-AR-000039096

Other devices from Compumedics Limited

See all devices from Compumedics Limited →

Properties

  • Measuring Function
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No