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Falcon HST
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 9036-0001-02Model Falcon HST SystemRef 8036-0003-01Model Falcon HST System EURef 9036-0001-07
Identity
- Device Name
- Falcon HST EUDAMED
- Model / Reference
- Falcon HST System EUDAMED9036-0001-02 EUDAMEDFalcon HST System EU EUDAMED8036-0003-01 EUDAMED9036-0001-07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09342451002785 EUDAMED09342451002754 EUDAMED09342451007636 EUDAMED
- Basic UDI-DI
- B-09342451002785 EUDAMED9342451FalconH9 EUDAMED
- EMDN Code
- Z12100501 POLYSOMNOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Falcon HST by Compumedics Limited — Class IIa — MDR, FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-09342451002785 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K242447 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-09342451002785 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Compumedics Limited
- EUDAMED SRN
- AU-MF-000050437
- Authorised Representative
- Compumedics EUROPE GmbH DE-AR-000039096
Sources (4)
- EUDAMED a5027d6a-5c96-4929-b6a3-66ab8ba97098 61 fields · synced Sep 18, 2026
- EUDAMED eaa08170-39aa-4701-95ce-a1c295098557 61 fields · synced Jul 19, 2026
- EUDAMED b8d05c49-8b03-4e12-a6c5-89131ed32f1b 61 fields · synced Sep 18, 2026
- FDA 510(k) K242447 1 fields · synced May 18, 2026