IDMED

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

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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) (8) Pupillometer, Ac-Powered (HLG) (2)

Premarket Exempt

No Yes

Clear

TOF-MU - 03665023000030 Catalog Number : TOF-MU

Device Description : Main unit ToFscan

Device Class : 2

Duns Number: 260233256

Premarket Exempt : No

Product Code : KOI

Prescription Use : Yes

Device Count : 1

TOF-S2 - 03665023000047 Catalog Number : TOF-S2

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-PS - 03665023000054 Catalog Number : TOF-PS

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-FS - 03665023000061 Catalog Number : TOF-FS

Device Description : Foot sensor and electrodes connector

Device Class : 2

Duns Number: 260233256

Premarket Exempt : No

Product Code : KOI

Prescription Use : Yes

Device Count : 1

TOF-ES - 03665023000078 Catalog Number : TOF-ES

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

TOF-CHAR_US - 03665023000122 Catalog Number : TOF-CHAR_US

Device Description : AC Power / Charger (US electrical sockets)

Device Class : 2

Duns Number: 260233256

Premarket Exempt : No

Product Code : KOI

Prescription Use : No

Device Count : 1

TOF-STICKER1 - 03665023000153 Catalog Number : TOF-STICKER1

Device Description : Double-sided stickers for eyebrow sensor (96 units)

Device Class :

Duns Number: 260233256

Premarket Exempt : No

Product Code : KOI

Prescription Use : Yes

Device Count : 96

NL-2 - 03665023000184 Catalog Number : NL-2

Device Description : NeuroLight kit (NeuroLight portable pupillometer NL-MU, wireless charging statio NeuroLight kit (NeuroLight portable pupillometer NL-MU, wireless charging station STA-W2, 10 eyecups EMB-NL, power supply PWR5-1_US, and user manual)

Device Class : 1

Duns Number: 260233256

Premarket Exempt : Yes

Product Code : HLG

Prescription Use : Yes

Device Count : 1

NL-MU - 03665023000191 Catalog Number : NL-MU

Device Description : Main unit NeuroLight

Device Class : 1

Duns Number: 260233256

Premarket Exempt : Yes

Product Code : HLG

Prescription Use : Yes

Device Count : 1

TOF-MU - 03665023000344 Catalog Number : TOF-MU

Device Description : Main unit ToFscan

Device Class : 2

Duns Number: 260233256

Premarket Exempt : No

Product Code : KOI

Prescription Use : Yes

Device Count : 1

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