SOMNOmedics GmbH

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) (7)

Premarket Exempt

No Yes

Clear

SOMNOscreen plus Accessory - 00833166000405 Catalog Number :

Device Class : 2

Duns Number: 314112173

Premarket Exempt : No

Product Code : MNR

Prescription Use : No

Device Count : 1

SOMNOscreen plus Accessory - 00833166000412 Catalog Number :

Device Class : 2

Duns Number: 314112173

Premarket Exempt : No

Product Code : MNR

Prescription Use : No

Device Count : 1

SOMNOscreen plus RC easy Set - 04250413400010 Catalog Number : SSP500U

Device Class :

Duns Number: 314112173

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

SOMNOscreen plus Cardio RESP Screener Set - 04250413400027 Catalog Number : SSP100U

Device Class :

Duns Number: 314112173

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

SOMNOscreen plus - 04250413400195 Catalog Number : SSP704

Device Class : 2

Duns Number: 314112173

Premarket Exempt : No

Product Code : MNR

Prescription Use : No

Device Count : 1

SOMNOscreen plus Accessory - 04250413400218 Catalog Number :

Device Class : 2

Duns Number: 314112173

Premarket Exempt : No

Product Code : MNR

Prescription Use : No

Device Count : 1

Pneumotachograph Set - 04250413400256 Catalog Number :

Device Class :

Duns Number: 314112173

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

SOMNOscreen plus Accessory - 04250413400348 Catalog Number :

Device Class : 2

Duns Number: 314112173

Premarket Exempt : No

Product Code : MNR

Prescription Use : No

Device Count : 1

Microphone for Snoring detection - 04250413400362 Catalog Number :

Device Class : 2

Duns Number: 314112173

Premarket Exempt : No

Product Code : MNR

Prescription Use : No

Device Count : 1

SOMNOscreen plus Accessory - 04250413400379 Catalog Number :

Device Class : 2

Duns Number: 314112173

Premarket Exempt : No

Product Code : MNR

Prescription Use : No

Device Count : 1

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