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

Cable, Electrode (IKD) (7) Electrode, Cutaneous (GXY) (3)

Premarket Exempt

No Yes

Clear

Alpine Biomed - 05704736000307 Catalog Number :

Device Description : Autoclaveable Concentric/Single Fiber Needle Cable 1 m, 5-pin DIN Connector

Device Class : 2

Duns Number: 311231554

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Alpine Biomed - 05704736000475 Catalog Number :

Device Description : Hand-held Bipolar Stimulator, Two 3 mm felt tips, diameter pads 10 mm apart, 2 m Hand-held Bipolar Stimulator, Two 3 mm felt tips, diameter pads 10 mm apart, 2 m cable, 5-pin DIN

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Alpine Biomed - 05704736000505 Catalog Number :

Device Description : Electrode Reusable Ground Plate, 1.25m Lead, TP connector

Device Class : 2

Duns Number: 311231554

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Alpine Biomed - 05704736000512 Catalog Number :

Device Description : Touchproof to 5-pin DIN Adaptor Cable, 2 x 1.5mm female TP

Device Class : 2

Duns Number: 311231554

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Alpine Biomed - 05704736000529 Catalog Number :

Device Description : HUSH™ Alligator Clip Electrode with 32' leads - Green

Device Class : 2

Duns Number: 311231554

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Alpine Biomed - 05704736000536 Catalog Number :

Device Description : HUSH™ Alligator Clip Electrode with 32' leads - Red

Device Class : 2

Duns Number: 311231554

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Alpine Biomed - 05704736000543 Catalog Number :

Device Description : Unshielded TP Extension Cable - 2x 1.5 mm TPC Male/ Female, 1 m

Device Class : 2

Duns Number: 311231554

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Alpine Biomed - 05704736000550 Catalog Number :

Device Description : HUSH™ Cable DIN Connector - 2 x 1.5 mm TPC, 1 m

Device Class : 2

Duns Number: 311231554

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Alpine Biomed - 05704736000567 Catalog Number :

Device Description : Digital Ring Electrode x 2, shielded 1m cable, 5-pin DIN connector

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Alpine Biomed - 05704736000581 Catalog Number :

Device Description : Large Digital Ring Electrodes, 1.2m lead, TP connectors

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

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