Identity
- Trade Name
- RETeval™ FDA UDI
- Generic Name
- Electroretinograph FDA UDI
- Device Name
- RETeval visual electrophysiology system - Complete model w/o Electrodes FDA UDI
- Model / Reference
- RETeval Complete w/o Electrodes FDA UDI
- Description
- RETeval visual electrophysiology system - Complete model w/o Electrodes FDA UDI
Identifiers
- Catalog Number
- RETeval Complete FDA UDI
- Primary DI / UDI-DI
- 00857901006477 FDA UDI
- 510(k) Number
- K142567 FDA UDI
- FDA Product Code
- HLG FDA UDIGWE FDA UDI
- GMDN Term
- Electroretinograph FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1700 FDA UDI882.1890 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
RETeval™ by LKC Technologies — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- LKC Technologies
Sources (1)
- FDA UDI 48925545-713b-44de-9a6e-8799f77e0d15 37 fields · synced May 30, 2026