Identity
- Trade Name
- IBEX Manual Refractor FDA UDI
- Generic Name
- Phoropter FDA UDI
- Device Name
- Manual Refractor is an ophthalmic testing device used to measure an individual’s refractive error and determine their eyeglass prescription. FDA UDI
- Model / Reference
- MR FDA UDI
- Description
- Manual Refractor is an ophthalmic testing device used to measure an individual’s refractive error and determine their eyeglass prescription. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00869228000465 FDA UDI
- FDA Product Code
- HKN FDA UDI
- GMDN Term
- Phoropter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1770 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Phoropter
IBEX Manual Refractor by Trevi Technology — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Phoropter.
- Computerized vision tester — Ningbo Ming Sing Optical R & D Co., Ltd. · Class I
- REFRACTOR — Nidek, Inc. · Class I
- IwavePhoropter — Krypton Vision (Suzhou) Ltd. · Class I
- Visionix — LUNEAU TECHNOLOGY OPERATIONS · Class I
- Medizs Digitalized Refractor DR-19 — MEDIZS Inc. · Class I
- YEASN — Chongqing Yeasn Science & Technology Co., Ltd. · 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
- Trevi Technology
Sources (1)
- FDA UDI e98193e2-6431-4a34-9c43-ba476b257e58 34 fields · synced Jun 8, 2026