Bittium Biosignals Oy

Bittium Biosignals Oy

Address:PIONEERINKATU 6,KUOPIO Pohjois-Savo,FI

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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, Biofeedback (HCC) (4) Transmitters And Receivers, Electrocardiograph, Telephone (DXH) (4) Perineometer (HIR) (2)

Premarket Exempt

No Yes

Clear

FemiScan - 06430035220014 Catalog Number :

Device Description : FemiScan device is for monitoring and recording muscle activity of the pelvic fl

Device Class : 2

Duns Number: 369960000

Premarket Exempt : No

Product Code : HIR

Prescription Use : Yes

Device Count : 1

FemiScan - 06430035220021 Catalog Number :

Device Description : Electrode for FemiScan HomeTrainer (HTCS) device. For single patient use.

Device Class : 2

Duns Number: 369960000

Premarket Exempt : No

Product Code : HIR

Prescription Use : Yes

Device Count : 1

Faros - 06430035220151 Catalog Number :

Device Description : Device for 1-channel ECG and motion measurement and data collection

Device Class : 2

Duns Number: 369960000

Premarket Exempt : No

Product Code : DXH

Prescription Use : Yes

Device Count : 1

Faros - 06430035220168 Catalog Number :

Device Description : Device for 1-channel ECG and motion measurement, monitoring and data collection

Device Class : 2

Duns Number: 369960000

Premarket Exempt : No

Product Code : DXH

Prescription Use : Yes

Device Count : 1

Faros - 06430035220175 Catalog Number :

Device Description : Device for 3-channel ECG and motion measurement, monitoring and data collection

Device Class : 2

Duns Number: 369960000

Premarket Exempt : No

Product Code : DXH

Prescription Use : Yes

Device Count : 1

ME6000 - 06430035220199 Catalog Number :

Device Description : ME6000 is a portable telemetry and data logger in measurement and monitoring of

Device Class : 2

Duns Number: 369960000

Premarket Exempt : No

Product Code : HCC

Prescription Use : Yes

Device Count : 1

ME6000 - 06430035220205 Catalog Number :

Device Description : ME6000 is a portable telemetry and data logger in measurement and monitoring of

Device Class : 2

Duns Number: 369960000

Premarket Exempt : No

Product Code : HCC

Prescription Use : Yes

Device Count : 1

ME6000 - 06430035220212 Catalog Number :

Device Description : ME6000 is a portable telemetry and data logger in measurement and monitoring of

Device Class : 2

Duns Number: 369960000

Premarket Exempt : No

Product Code : HCC

Prescription Use : Yes

Device Count : 1

eMotion ECG - 06430035220229 Catalog Number :

Device Description : Device for 1-channel ECG monitoring

Device Class : 2

Duns Number: 369960000

Premarket Exempt : No

Product Code : DXH

Prescription Use : Yes

Device Count : 1

ME6000 - 06430035220236 Catalog Number :

Device Description : ME6000 is a portable telemetry and data logger in measurement and monitoring of

Device Class : 2

Duns Number: 369960000

Premarket Exempt : No

Product Code : HCC

Prescription Use : Yes

Device Count : 1

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