Identity
- Trade Name
- NeurOptics FDA UDI
- Generic Name
- Pupillograph FDA UDI
- Model / Reference
- NPi-200 System FDA UDI
Identifiers
- Catalog Number
- NPi-200 Kit FDA UDI
- Primary DI / UDI-DI
- 00850010118079 FDA UDI
- FDA Product Code
- HLG FDA UDI
- GMDN Term
- Pupillograph FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Pupillograph
NeurOptics by NeurOptics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- NeurOptics — NeurOptics, Inc. · Class I
- NeurOptics — NeurOptics, Inc. · Class I
- NeurOptics — NeurOptics, Inc. · Class I
- NeurOptics — NeurOptics, Inc. · Class I
- NeurOptics — NeurOptics, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- NeurOptics, Inc.
Sources (1)
- FDA UDI 04422430-ff90-451f-9fe1-f73f7f4dc67d 35 fields · synced Jun 8, 2026