Alpine Biomed ApS

Alpine Biomed ApS

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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

Stimulator, Electrical, Evoked Response (GWF) (9) Amplifier, Physiological Signal (GWL) (1) Stimulator, Nerve, Battery-Powered (BXN) (1)

Premarket Exempt

No Yes

Clear

Alpine BioMed - 00613994197580 Catalog Number :

Device Description : Clavis EMG/ Stim Device

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWL, BXN

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 00613994242297 Catalog Number :

Device Description : KEYPOINT WS UKXP-OS

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 00673978206981 Catalog Number :

Device Description : 2 CHANNEL EMG/EP AMPLI-

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 00673978206998 Catalog Number :

Device Description : 4 CH. AMP BOX/ARM KEYPOINT

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 00673978212043 Catalog Number :

Device Description : ACTIVE HANDGRIP FOR KP G3

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine Biomed - 00673978875644 Catalog Number :

Device Description : MULTI STIM, 2 M CABLE

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 00681490508865 Catalog Number :

Device Description : 4 CH. AMP.BOX/ARM, KEYPOINT

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 00681490853149 Catalog Number :

Device Description : 4 CH EP ADC BOARD FOR KEYPOINT

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 00681490920650 Catalog Number :

Device Description : 2-channel EMG/EP Amplifier with 1.7 m cable

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine Biomed - 00681490920667 Catalog Number :

Device Description : 4 ch Amp- EMG/EP Amplifier with 1.7 m cable

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

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