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) Electrode, Depth (GZL) (1)

Premarket Exempt

No Yes

Clear

Alpine BioMed - 05704736017794 Catalog Number :

Device Description : "Keypoint Focus Workstation, DANIncluding:- USFF PC with Keypoint software, 22” "Keypoint Focus Workstation, DANIncluding:- USFF PC with Keypoint software, 22” display- Keypoint Focus main unit with control panel, integrated speakers, EP stimulators- Cart with isolating power supply- System kit"

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736017879 Catalog Number :

Device Description : CC STIM HANGRIP

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736018012 Catalog Number :

Device Description : Notebook kit, Focus

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736018272 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 - 05704736018296 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

Alpine BioMed - 05704736018302 Catalog Number :

Device Description : 6-ch. EMG/EP Amplifier

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736018319 Catalog Number :

Device Description : 8-ch. EMG/EP Amplifier

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736018371 Catalog Number :

Device Description : Advanced Stimulation Handgrip

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736018395 Catalog Number :

Device Description : Single CC Stim

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736018401 Catalog Number :

Device Description : Multi CC Stim

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

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