NeuroLight
by Idmed France EUDAMEDGUDID
Ref NL-2-DEMModel NL-System
Product code HLGEMDN Z12040180
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number3665023NL-System5K | Date7 Nov 2025 | StatusActive |
| United States | GUDID listing GUDID | Number03665023000627 | Date10 Jun 2022 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- NeuroLight EUDAMEDNl-2-Dem GUDID
- Generic Name
- Pupillograph
- Model / Ref / Catalog
- NL-System, NL-2-DEM
- Primary DI / UDI-DI
- 03665023000627
- Basic UDI-DI
- 3665023NL-System5K
- Direct Marketing DI
- 03665023000627
- FDA Product Code
- HLG
- EMDN Code
- Z12040180 General medicine diagnosis and monitoring instruments - hardware accessories
- GMDN Term
- Pupillograph
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 886.1700
- Market of Registration
- France
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class I |
Manufacturer details
- EUDAMED SRN
- FR-MF-000002402
Other devices from Idmed
Properties & raw data
Show properties, registry sources and raw records
Other properties (19)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
- Expiration Date: No
Sources (2)
- EUDAMED c0472179-b13e-4e57-8171-528c18087e69
- FDA UDI bd39ea2e-bf72-432a-b48e-e60e2247ffe2