Identity
- Trade Name
- NeuroColor FDA UDI
- Generic Name
- Colour discrimination tester FDA UDI
- Device Name
- An ophthalmic device that consists of various coloured materials, e.g., coloured yarns or colour vision plates (multicoloured plates which patients with colour vision deficiency would perceive as being of one colour), used for evaluating colour vision. FDA UDI
- Model / Reference
- COLOR-01 FDA UDI
- Description
- An ophthalmic device that consists of various coloured materials, e.g., coloured yarns or colour vision plates (multicoloured plates which patients with colour vision deficiency would perceive as being of one colour), used for evaluating colour vision. FDA UDI
Identifiers
- Catalog Number
- NC01 FDA UDI
- Primary DI / UDI-DI
- G506NC010 FDA UDI
- FDA Product Code
- HIT FDA UDI
- GMDN Term
- Colour discrimination tester FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1170 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Colour discrimination tester
NeuroColor by AMA Optics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- AMA Optics, Inc.
Sources (1)
- FDA UDI 3c831810-e6fe-43d9-9348-3d601b1ae38f 34 fields · synced Jun 8, 2026