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) (8) Amplifier, Physiological Signal (GWL) (1) Electrode, Depth (GZL) (1) Stimulator, Nerve, Battery-Powered (BXN) (1)

Premarket Exempt

No Yes

Clear

Alpine BioMed - 05704736008822 Catalog Number :

Device Description : 6-ch. Amplifier, G4

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736008839 Catalog Number :

Device Description : 8-ch. Amplifier, G4

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736008846 Catalog Number :

Device Description : Single CC Stim, G4

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736008853 Catalog Number :

Device Description : Multi CC Stim, G4

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736009195 Catalog Number :

Device Description : Keypoint G4 config. kit

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736009546 Catalog Number :

Device Description : CLAVIS, DEVICE COMPLETE

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWL, BXN

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736010269 Catalog Number :

Device Description : FRONT END BOX, KEYPOINT G4

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736010276 Catalog Number :

Device Description : CONTROL PANEL, KEYPOINT G4

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736010283 Catalog Number :

Device Description : Keypoint G4

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736014946 Catalog Number :

Device Description : 3CH. AMPLIFIER BOX.

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

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