Medidata Solutions, Inc.

Medidata Solutions, Inc.

Address:110 High St,Boston,MA,02110,US

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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

Device, Sleep Assessment (LEL) (10) Electromyograph, Diagnostic (IKN) (10) Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (MWI) (10) Transmitters And Receivers, Physiological Signal, Radiofrequency (DRG) (10)

Premarket Exempt

No

Clear

BioStamp® nPoint - G012BRCA02 Catalog Number :

Device Description : Adhesive with hydrogel

Device Class : 2

Duns Number: 840371087

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

BioStamp® - G012BRCA05 Catalog Number :

Device Description : Adhesive Applicator

Device Class : 2

Duns Number: 840371087

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

BioStamp® - G012BRCD02 Catalog Number :

Device Description : Link Hub Smart Charger

Device Class : 2

Duns Number: 840371087

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

BioStamp nPoint™ - G012BRCP01 Catalog Number :

Device Description : Mobile application phone

Device Class : 2

Duns Number: 840371087

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

BioStamp® nPoint - G012BRCP02 Catalog Number :

Device Description : Mobile application phone

Device Class : 2

Duns Number: 840371087

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

BioStamp® - G012BRCP03 Catalog Number :

Device Description : Mobile phone application

Device Class : 2

Duns Number: 840371087

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

BioStamp® - G012BRCS02 Catalog Number :

Device Description : Wearable sensor patch

Device Class : 2

Duns Number: 840371087

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

BioStamp nPoint™ - G012BRCT01 Catalog Number :

Device Description : Mobile Application tablet

Device Class : 2

Duns Number: 840371087

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

BioStamp® - G012BSPS01 Catalog Number :

Device Description : Link Hub smart charger power supply

Device Class : 2

Duns Number: 840371087

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

BioStamp® nPoint - G012MC00022 Catalog Number :

Device Description : Clinical Investigations Kit containing BRCS02 Wearable Sensor Patch, BRCD02 Smar Clinical Investigations Kit containing BRCS02 Wearable Sensor Patch, BRCD02 Smart Charger, BSPS01 Medical Power Supply, BRCA05 Adhesive Applicator, BRCP03 Phone

Device Class : 2

Duns Number: 840371087

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : No

Device Count : 1

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