SOMNOmedics GmbH

Address:AM SONNENSTUHL 63,RANDERSACKER Bavaria,DE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Ventilatory Effort Recorder (MNR) (4)

Premarket Exempt

No Yes

Clear

Inductive Effort belt - size XXXL - 04250413410521 Catalog Number :

Device Class : 2

Duns Number: 314112173

Premarket Exempt : No

Product Code : MNR

Prescription Use : No

Device Count : 1

SOMNO RESP accessory - 04250413410538 Catalog Number :

Device Class : 2

Duns Number: 314112173

Premarket Exempt : No

Product Code : MNR

Prescription Use : No

Device Count : 1

SOMNOscreen HD PSG - 04250413410644 Catalog Number :

Device Class :

Duns Number: 314112173

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

SOMNOscreen HD PSG Tele - 04250413410651 Catalog Number :

Device Class :

Duns Number: 314112173

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

SOMNOscreen HD PSG with Camera COMPACT - 04250413410668 Catalog Number :

Device Class :

Duns Number: 314112173

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

SOMNOscreen HD EEG32 - 04250413410675 Catalog Number :

Device Class :

Duns Number: 314112173

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

SOMNOscreen HD EEG 32 Set 2 - 04250413410682 Catalog Number :

Device Class :

Duns Number: 314112173

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

SOMNOscreen HD EEG32 with Camera - 04250413410699 Catalog Number :

Device Class :

Duns Number: 314112173

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Set for wireless PLM measurement - 04250413410705 Catalog Number :

Device Class : 2

Duns Number: 314112173

Premarket Exempt : No

Product Code : MNR

Prescription Use : No

Device Count : 1

1 channel ECG sensor including body position and disposable electrodes - 04250413410712 Catalog Number :

Device Class : 2

Duns Number: 314112173

Premarket Exempt : No

Product Code : MNR

Prescription Use : No

Device Count : 1

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