Identity
- Trade Name
- ERG-Jet FDA UDI
- Generic Name
- Electroretinograph electrode FDA UDI
- Device Name
- The ERG-Jet is a contact lens for performing an electroretinogram, or ERG, provocated by light stimulation of the retina in either humans or animals. The electrode is made of a gold ring just a few angstroms (10-10 meter) thick, which can be safely placed in contact with the cornea using a viscous conductive liquid. FDA UDI
- Model / Reference
- F06 FDA UDI
- Description
- The ERG-Jet is a contact lens for performing an electroretinogram, or ERG, provocated by light stimulation of the retina in either humans or animals. The electrode is made of a gold ring just a few angstroms (10-10 meter) thick, which can be safely placed in contact with the cornea using a viscous conductive liquid. FDA UDI
Identifiers
- Primary DI / UDI-DI
- EFABF062 FDA UDI
- FDA Product Code
- HLZ FDA UDI
- GMDN Term
- Electroretinograph electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1220 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 12 Millimeter FDA UDI
Category: Electroretinograph electrode
ERG-Jet by Fabrinal SA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Electroretinograph electrode.
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- RETeval™ — LKC Technologies · Class I
- RETeval™ — LKC Technologies · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fabrinal SA
Sources (2)
- FDA UDI 1e11510e-4d78-4d52-a184-e039bfb2bffd 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026