IDMED

Address:3 rue John Maynard Keynes,Marseille Bouches-du-Rhone,FR

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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) (9) Pupillometer, Ac-Powered (HLG) (1)

Premarket Exempt

No Yes

Clear

TOF - 03665023000351 Catalog Number : TOF

Device Description : Complete ToFscan Kit (TOF-MU, TOF-CHAR_US AC power/charger, clamp, TOF-S2 sensor Complete ToFscan Kit (TOF-MU, TOF-CHAR_US AC power/charger, clamp, TOF-S2 sensor, cable support, user manual)

Device Class : 2

Duns Number: 260233256

Premarket Exempt : No

Product Code : KOI

Prescription Use : Yes

Device Count : 1

TOF-DEMO - 03665023000368 Catalog Number : TOF-DEMO

Device Description : Complete ToFscan Kit with robust demonstration case for ToFscan and its accessor Complete ToFscan Kit with robust demonstration case for ToFscan and its accessories (TOF-MU, TOF-CHAR_US AC power/charger, clamp, TOF-S2_B sensor, cable support, user manual)

Device Class : 2

Duns Number: 260233256

Premarket Exempt : No

Product Code : KOI

Prescription Use : Yes

Device Count : 1

TOF-DEMO_F - 03665023000375 Catalog Number : TOF-DEMO_F

Device Class : 2

Duns Number: 260233256

Premarket Exempt : No

Product Code : KOI

Prescription Use : Yes

Device Count : 1

STA-W2 - 03665023000429 Catalog Number : STA-W2

Device Description : Wireless charging station

Device Class : 1

Duns Number: 260233256

Premarket Exempt : Yes

Product Code : HLG

Prescription Use : Yes

Device Count : 1

TOF-PS2_B - 03665023000450 Catalog Number : TOF-PS2_B

Device Description : Small Pediatric Hand sensor and electrodes connector

Device Class : 2

Duns Number: 260233256

Premarket Exempt : No

Product Code : KOI

Prescription Use : Yes

Device Count : 1

TOF-DS1 - 03665023000467 Catalog Number : TOF-DS1

Device Description : Disposable 3D-AMG hand sensor with stimulation electrodes

Device Class : 2

Duns Number: 260233256

Premarket Exempt : No

Product Code : KOI

Prescription Use : Yes

Device Count : 1

TOF-CS1 - 03665023000474 Catalog Number : TOF-CS1

Device Description : Cable to connect disposable hand sensor to the ToFscan

Device Class : 2

Duns Number: 260233256

Premarket Exempt : No

Product Code : KOI

Prescription Use : Yes

Device Count : 1

TOF-PS_B - 03665023000481 Catalog Number : TOF-PS_B

Device Description : Pediatric Hand sensor and electrodes connector

Device Class : 2

Duns Number: 260233256

Premarket Exempt : No

Product Code : KOI

Prescription Use : Yes

Device Count : 1

TOF-S2_B - 03665023000498 Catalog Number : TOF-S2_B

Device Description : Hand sensor and electrodes connector

Device Class : 2

Duns Number: 260233256

Premarket Exempt : No

Product Code : KOI

Prescription Use : Yes

Device Count : 1

TOF-ES_B - 03665023000504 Catalog Number : TOF-ES_B

Device Description : Eyebrow sensor and electrodes connector

Device Class : 2

Duns Number: 260233256

Premarket Exempt : No

Product Code : KOI

Prescription Use : Yes

Device Count : 1

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