SMART SOLUTIONS TECHNOLOGIES SL

Address:P. Castellana n 200, 5 floor Madrid 28046,madrid Madrid (Province),ES

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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

RECORDER, MAGNETIC TAPE, MEDICAL (DSH) (4) Computer, diagnostic, programmable (DQK) (1)

Premarket Exempt

Clear

Nuubo System - 08437011759016 Catalog Number : 2020

Device Description : Nuubo30 SI Box USA. Textile with an integrated electrodes technology for sensin Nuubo30 SI Box USA. Textile with an integrated electrodes technology for sensing the patient’s ECG.

Device Class : 2

Duns Number: 475359621

Premarket Exempt : No

Product Code : DSH

Prescription Use : No

Device Count : 1

Nuubo System - 08437011759023 Catalog Number : 2021

Device Description : Nuubo30 SII Box USA. Textile with an integrated electrodes technology for sensi Nuubo30 SII Box USA. Textile with an integrated electrodes technology for sensing the patient’s ECG.

Device Class : 2

Duns Number: 475359621

Premarket Exempt : No

Product Code : DSH

Prescription Use : No

Device Count : 1

Nuubo System - 08437011759030 Catalog Number : 2022

Device Description : Nuubo30 SIII Box USA. Textile with an integrated electrodes technology for sens Nuubo30 SIII Box USA. Textile with an integrated electrodes technology for sensing the patient’s ECG.

Device Class : 2

Duns Number: 475359621

Premarket Exempt : No

Product Code : DSH

Prescription Use : No

Device Count : 1

Nuubo System - 08437011759078 Catalog Number : 2140

Device Description : NuuboREC Box USA. Ambulatory ECG monitoring device (Holter) up to 30 days.

Device Class : 2

Duns Number: 475359621

Premarket Exempt : No

Product Code : DSH

Prescription Use : No

Device Count : 1

Nuubo System - 08437011759092 Catalog Number : 1935

Device Description : Nuubo Leonardo Box USA. Software for downloading, analysis, visualization and re Nuubo Leonardo Box USA. Software for downloading, analysis, visualization and report of the ECG-data stored by the recorder device and for managing the recorder device.

Device Class : 2

Duns Number: 475359621

Premarket Exempt : No

Product Code : DQK

Prescription Use : No

Device Count : 1

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