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) (6) Cable, Electrode (IKD) (4)

Premarket Exempt

No Yes

Clear

Alpine BioMed - 00885074292007 Catalog Number :

Device Description : LEADPOINT WORKSTATION 5+3, IT

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 00885074292014 Catalog Number :

Device Description : LEADPOINT WORKSTATION 5+3, US

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 00885074322889 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 - 00885074322919 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

Alpine Biomed - 00885074326696 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 - 00885074326702 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 - 05704736000147 Catalog Number :

Device Description : HUSH™ 80cm Unshielded Extension lead wires , electrode end 0.7 mm, 1.5 mm female HUSH™ 80cm Unshielded Extension lead wires , electrode end 0.7 mm, 1.5 mm female touch proof connector

Device Class : 2

Duns Number: 311231554

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Alpine Biomed - 05704736000253 Catalog Number :

Device Description : HUSH Yoke Short 10 cm long cable, 5 pole straight DIN

Device Class : 2

Duns Number: 311231554

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Alpine Biomed - 05704736000260 Catalog Number :

Device Description : HUSH Yoke Long 4 m long cable, 5-pole right angle DIN

Device Class : 2

Duns Number: 311231554

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Alpine Biomed - 05704736000284 Catalog Number :

Device Description : Leadpoint Stimulus Adaptor

Device Class : 2

Duns Number: 311231554

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

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