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) (10)

Premarket Exempt

No Yes

Clear

Alpine Biomed - 00681490920674 Catalog Number :

Device Description : 8-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 - 00681490920704 Catalog Number :

Device Description : EP Headbox incl. 1.5m Cable

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 00721902428500 Catalog Number :

Device Description : 2 CH. AMPLIFIER

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 00721902428517 Catalog Number :

Device Description : 4 CH. AMPLIFIER

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 00721902428524 Catalog Number :

Device Description : 8 CH. AMPLIFIER

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 00721902428531 Catalog Number :

Device Description : EP HEADBOX UNIT

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine Biomed - 00721902565236 Catalog Number :

Device Description : SINGLE CONSTANT CURRENT STIMULATOR, CABLE 0.85 M

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine Biomed - 00721902796227 Catalog Number :

Device Description : 5CH. PREAMPL. BOX. FOR LEAD- POINT

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 00885074291499 Catalog Number :

Device Description : KEYPOINT WORKST UK

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 00885074291529 Catalog Number :

Device Description : KEYPOINT WORKST FR

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

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