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

Premarket Exempt

No Yes

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TOF-FS_B - 03665023000511 Catalog Number : TOF-FS_B

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-D - 03665023000597 Catalog Number : TOF-D

Device Description : Complete ToFscan Kit (TOF-MU, TOF-CHAR_US AC power charger, clamp, TOF-CS1 cable Complete ToFscan Kit (TOF-MU, TOF-CHAR_US AC power charger, clamp, TOF-CS1 cable, cable support, user manual)

Device Class : 2

Duns Number: 260233256

Premarket Exempt : No

Product Code : KOI

Prescription Use : Yes

Device Count : 1

NL-2-DEM - 03665023000627 Catalog Number : NL-2-DEM

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

Device Class : 1

Duns Number: 260233256

Premarket Exempt : Yes

Product Code : HLG

Prescription Use : Yes

Device Count : 1

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