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) (8) Electrode, Cutaneous (GXY) (2)

Premarket Exempt

No Yes

Clear

Alpine Biomed - 05704736000598 Catalog Number :

Device Description : HUSH Reusable Bar Electrode, 2 x 10 mm discs, 30mm apart,shielded 1m cable, 5-pi HUSH Reusable Bar Electrode, 2 x 10 mm discs, 30mm apart,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 - 05704736000611 Catalog Number :

Device Description : HUSH Reusable Disc Electrodes, 2 x 10 mm discs, 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 - 05704736000680 Catalog Number :

Device Description : ADAPT,2MM M X 1.5MM M TP,BLACK

Device Class : 2

Duns Number: 311231554

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Alpine Biomed - 05704736000918 Catalog Number :

Device Description : HUSH™ 1m Cable, Disp. Surface and Sensory Needles, 2 x 0.7 mm female electrode e HUSH™ 1m Cable, Disp. Surface and Sensory Needles, 2 x 0.7 mm female electrode ends, 5 pole DIN connector

Device Class : 2

Duns Number: 311231554

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Alpine Biomed - 05704736000925 Catalog Number :

Device Description : HUSH™ 2m Cable, Disp. Surface and Sensory Needles, 2 x 0.7 mm female electrode e HUSH™ 2m Cable, Disp. Surface and Sensory Needles, 2 x 0.7 mm female electrode ends, 5 pole DIN connector

Device Class : 2

Duns Number: 311231554

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Alpine Biomed - 05704736000932 Catalog Number :

Device Description : HUSH™ 1m cable for Disposable Surface Shielded and Sensory Needle Electrodes 3 x HUSH™ 1m cable for Disposable Surface Shielded and Sensory Needle Electrodes 3 x 0.7 mm 5 pole DIN

Device Class : 2

Duns Number: 311231554

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Alpine Biomed - 05704736000949 Catalog Number :

Device Description : HUSH™ 2m Shielded cable for Disposable Surface Shielded and Sensory Needle Elect HUSH™ 2m Shielded cable for Disposable Surface Shielded and Sensory Needle Electrodes, electrode end 3 x 0.7 mm, 5-pin DIN connector

Device Class : 2

Duns Number: 311231554

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Alpine Biomed - 05704736000970 Catalog Number :

Device Description : HUSH Alligator Clip Cable, Shielded, 39", 5-pin DIN to red, black, green alligator clips

Device Class : 2

Duns Number: 311231554

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Alpine Biomed - 05704736000987 Catalog Number :

Device Description : HUSH™ 2m Unshielded Extension lead wires , electrode end 0.7 mm, 1.5 mm female t HUSH™ 2m 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 - 05704736000994 Catalog Number :

Device Description : HUSH Yoke 1.5 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

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