Senzime AB (Publ.)

Address:Ulls vag 41,Uppsala,SE

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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, Nerve, Peripheral, Electric (KOI) (6)

Premarket Exempt

Clear

TetraGraph - 07350012440015 Catalog Number : SEN 2001

Device Description : TetraGraph Neuromuscular Transmission Monitor

Device Class : 2

Duns Number: 559976316

Premarket Exempt : No

Product Code : KOI

Prescription Use : Yes

Device Count : 1

TetraSens - 07350012440022 Catalog Number : SEN 2002

Device Description : TetraSens TetraGraph Electrode

Device Class : 2

Duns Number: 559976316

Premarket Exempt : No

Product Code : KOI

Prescription Use : Yes

Device Count : 1

TetraGraph Pole Clamp kit - 07350012440091 Catalog Number : SEN 2101

Device Description : TetraGraph Pole Clamp kit (Optional to use with TetraGraph)

Device Class : 2

Duns Number: 559976316

Premarket Exempt : No

Product Code : KOI

Prescription Use : No

Device Count : 1

TetraGraph Philips Interface - 07350012440107 Catalog Number : SEN 2007

Device Description : TetraGraph Philip Interface (Optional to use with TetraGraph)

Device Class : 2

Duns Number: 559976316

Premarket Exempt : No

Product Code : KOI

Prescription Use : Yes

Device Count : 1

TetraSens Pediatric - 07350012440121 Catalog Number : SEN 2009

Device Description : TetraSens Pediatric electrode

Device Class : 2

Duns Number: 559976316

Premarket Exempt : No

Product Code : KOI

Prescription Use : Yes

Device Count : 1

TetraGraph Xcom - 07350012440145 Catalog Number : SEN 2010

Device Description : TetraGraph Xcom (Optional to use with TetraGraph)

Device Class : 2

Duns Number: 559976316

Premarket Exempt : No

Product Code : KOI

Prescription Use : Yes

Device Count : 1

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