Tracey-VFA Visual Function Analyzer
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- iTrace EUDAMEDTracey-VFA Visual Function Analyzer FDA UDI
- Generic Name
- Corneal topography system FDA UDI
- Device Name
- Tracey VFA Visual Function Analyzer EUDAMEDThe iTrace is used to measure the refractive, wavefront and corneal topographic data of the human optical system. FDA UDI
- Model / Reference
- iTrace EUDAMEDFDA UDIZ2000 EUDAMED
- Description
- The iTrace is used to measure the refractive, wavefront and corneal topographic data of the human optical system. FDA UDI
Identifiers
- Catalog Number
- Z2000 FDA UDI
- Primary DI / UDI-DI
- 00860479001706 EUDAMEDFDA UDI
- Basic UDI-DI
- 08604790017Z2000NN EUDAMED
- Direct Marketing DI
- 00860479001706 EUDAMED
- FDA Product Code
- NCF FDA UDI
- EMDN Code
- Q0299,V030203 EUDAMED
- GMDN Term
- Corneal topography system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.1760 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Automated ophthalmic refractometerCorneal topography system
Tracey-VFA Visual Function Analyzer by Tracey Technologies, Corp. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Corneal topography system.
- TOPOGRAPHIC MODELING SYSTEM — Tomey Corporation · Class I
- MYOPIA EXPERT 700 — VISIA IMAGING SRL · Class II
- Keratograph 5M — OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung · Class I
- MYAH — VISIA IMAGING SRL · Class II
- WAVELIGHT ALLEGRO TOPOLYZER — Alcon Laboratories, Inc. · Class III
- WAVE ANALYZER MEDICA 800 — ESSILOR INTERNATIONAL · Class II
- Topographic Modeling System — Tomey Corporation · Class I
- CASSINI — Cassini Technologies B.V. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tracey Technologies, Corp.
Sources (2)
- FDA UDI 35035323-c3d7-43c3-a039-eed05c58af81 34 fields · synced Jul 10, 2026
- EUDAMED 2e45858e-ca94-46a0-a949-a10d1811401b 61 fields · synced Jul 10, 2026