Identity
- Trade Name
- AMA Optics Retinometer FDA UDI
- Generic Name
- Vision testing/training chart FDA UDI
- Device Name
- An ophthalmic retro-illuminated chart printed with various symbols (letters, numbers, pictures, dots) intended to be used for testing visual acuity (e.g., Snellen chart) for routine visual function examination (e.g., preoperative visual acuity prediction and postoperative visual acuity recovery assessment for cataract, glaucoma, retinopathy, amblyopia, etc.). FDA UDI
- Model / Reference
- RAM-01-O FDA UDI
- Description
- An ophthalmic retro-illuminated chart printed with various symbols (letters, numbers, pictures, dots) intended to be used for testing visual acuity (e.g., Snellen chart) for routine visual function examination (e.g., preoperative visual acuity prediction and postoperative visual acuity recovery assessment for cataract, glaucoma, retinopathy, amblyopia, etc.). FDA UDI
Identifiers
- Catalog Number
- RAM02 FDA UDI
- Primary DI / UDI-DI
- G506RAM20 FDA UDI
- FDA Product Code
- HOX FDA UDI
- GMDN Term
- Vision testing/training chart FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1150 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: Vision testing/training chart
AMA Optics Retinometer 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 6ee2f68e-1c6e-44a0-b7a9-7b6d25d41006 34 fields · synced Jun 6, 2026