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NeurOptics
EUDAMEDFDA UDIClass I (EU MDR)
Ref NPi-300-SYSModel NPi-300 Pupilometer System
Identity
- Trade Name
- NeurOptics EUDAMEDFDA UDI
- Generic Name
- Pupillograph FDA UDI
- Device Name
- NPi-300 Pupilometer System EUDAMED
- Model / Reference
- NPi-300 Pupilometer System EUDAMEDFDA UDINPi-300-SYS EUDAMED
Identifiers
- Catalog Number
- NPi-300-SYS FDA UDI
- Primary DI / UDI-DI
- 00850010118024 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00850010118024 EUDAMED
- FDA Product Code
- HLG FDA UDI
- EMDN Code
- Z12120125 PUPILLOMETERS EUDAMED
- GMDN Term
- Pupillograph FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1700 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
NeurOptics by NeurOptics, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00850010118024 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- NeurOptics, Inc.
- EUDAMED SRN
- US-MF-000013240
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED fe5f9a13-08ca-4e2f-b3fb-238a118b175e 61 fields · synced May 30, 2026
- FDA UDI f70bb157-e6f4-4e7e-9c23-3173385b3e55 34 fields · synced May 30, 2026