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COMPUMEDICS LIMITED

Australia·AU-MF-000050437

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Somfit Electrode with Prep Pad	7037-1001-00	EUDAMED	Class I	Active
Somfit System	8037-0101-00	EUDAMED	Class IIa	Active
Somfit System	9037-0016-02	EUDAMED	Class IIa	Active
Okti	9029-0005-01	EUDAMED	Class IIa	Active
SynAmps2/RT	9032-0001-01	EUDAMEDFDA UDI	Class IIa	Active
Somfit System	9037-0012-00	EUDAMED	Class IIa	Active
Somfit D	K252383	FDA 510(k)	Class II	Active
Orion LifeSpan MEG	K191785	FDA 510(k)	Class II	Active
Compumedics Somte Psg Recording System	K072201	FDA 510(k)	Class II	Active
Compumedics Siesta System	K003175	FDA 510(k)	Class II	Active
Grael	9028-0002-04	EUDAMED	Class IIa	Active
SynAmps2/RT	9032-0002-01	EUDAMEDFDA UDI	Class IIa	Active
Curry	8238-0044-01	EUDAMED	Class IIa	Active
Grael	9028-0005-01	EUDAMED	Class IIa	Active
SynAmps2/RT	9032-0003-01	EUDAMEDFDA UDI	Class IIa	Active
Okti	9029-0004-01	EUDAMED	Class IIa	Active
Okti	9029-0007-01	EUDAMED	Class IIa	Active
Grael	9028-0001-02	EUDAMEDFDA UDI	Class IIa	Active
Grael	9028-0009-01	EUDAMEDFDA UDI	Class IIa	Active
Grael	9028-0008-01	EUDAMEDFDA UDI	Class IIa	Active
Neuvo	9022-0004-01	EUDAMEDFDA UDI	Class IIa	Active
Falcon HST	9036-0001-02	EUDAMED	Class IIa	Active
Profusion EEG	8208-0063-01	EUDAMED	Class IIa	Active
Profusion PSG	8200-1030-00	EUDAMED	Class IIa	Active
Somfit System	9037-0002-00	EUDAMED	Class IIa	Active
Somté PSG	9023-0002-01	EUDAMEDFDA UDI	Class IIa	Active
Somfit Pro System	9037-0016-00	EUDAMED	Class IIa	Active
Okti	9029-0016-01	EUDAMEDFDA UDI	Class IIa	Active
Grael	9028-0020-02	EUDAMEDFDA 510(k)	Class IIa	Active

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