Identity
- Trade Name
- AMA Optics Amblyometer FDA UDI
- Generic Name
- Binocular vision test unit FDA UDI
- Device Name
- An ophthalmic device for binocular vision testing. The patient views a two image pairs stacked (Top = right dim image/left bright image; Bottom = right bright image//left dim image) through polarizing glasses of a polarizing system and informs the examining doctor when the combination perceived changes. This visual impression provides the information whereby a diagnosis of unconscious suppression of one eye can be determined. FDA UDI
- Model / Reference
- Amblyo-01 FDA UDI
- Description
- An ophthalmic device for binocular vision testing. The patient views a two image pairs stacked (Top = right dim image/left bright image; Bottom = right bright image//left dim image) through polarizing glasses of a polarizing system and informs the examining doctor when the combination perceived changes. This visual impression provides the information whereby a diagnosis of unconscious suppression of one eye can be determined. FDA UDI
Identifiers
- Catalog Number
- AMBLYO01 FDA UDI
- Primary DI / UDI-DI
- G506AMBYO010 FDA UDI
- FDA Product Code
- HLC FDA UDI
- GMDN Term
- Binocular vision test unit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1460 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: Binocular vision test unit
AMA Optics Amblyometer by AMA Optics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 657a2ae9-4b7d-4e71-a61b-d6a1d20ed705 34 fields · synced Jun 1, 2026