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

Electrode, Depth (GZL) (9) Stimulator, Electrical, Evoked Response (GWF) (1)

Premarket Exempt

No Yes

Clear

Alpine BioMed - 05704736018418 Catalog Number :

Device Description : 6-ch. EP Amplifier

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736018494 Catalog Number :

Device Description : MER AMPLIFIER FOR LEADPOINT FOCUS

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736018722 Catalog Number :

Device Description : LEADPOINT FOCUS NOTEBOOK SYSTEM, US 115V

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736018739 Catalog Number :

Device Description : LP Focus Notebook system, UK

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736018746 Catalog Number :

Device Description : LP Focus Notebook syst, FR CAN

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736018753 Catalog Number :

Device Description : LP Focus Notebook system, 115V

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736018760 Catalog Number :

Device Description : LEADPOINT FOCUS NOTEBOOK SYSTEM, INT!. 230V

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736018777 Catalog Number :

Device Description : LP Focus Notebook system, F

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736018784 Catalog Number :

Device Description : LP Focus Notebook system, G

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736018791 Catalog Number :

Device Description : LP Focus Notebook system, E

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

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