Identity
- Trade Name
- DTL Plus Electrodes EUDAMEDDTL FDA UDI
- Generic Name
- Electroretinograph electrode FDA UDI
- Device Name
- DTL Plus Electrodes EUDAMEDA non-sterile electrical conductor intended to be applied adjacent to the eye to transmit an electrical signal during an evaluation of the eye's retina. It is typically in the form of a conductive thread that is laid along the lower eyelid in contact with the tear film and cornea. The general device that records this electrical activity is the electroretinograph (ERG). This is a single-use device. FDA UDI
- Model / Reference
- D141 EUDAMEDFDA UDI
- Description
- A non-sterile electrical conductor intended to be applied adjacent to the eye to transmit an electrical signal during an evaluation of the eye's retina. It is typically in the form of a conductive thread that is laid along the lower eyelid in contact with the tear film and cornea. The general device that records this electrical activity is the electroretinograph (ERG). This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- D141 FDA UDI
- Primary DI / UDI-DI
- 00850594007011 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00850594007011 EUDAMED
- FDA Product Code
- HLZ FDA UDI
- EMDN Code
- Q029002 OPHTHALMOLOGICAL DIAGNOSTIC ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Electroretinograph electrode FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1220 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
DTL Plus Electrodes by Diagnosys Llc — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00850594007011 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Diagnosys LLC
- EUDAMED SRN
- US-MF-000002934
- Authorised Representative
- Diagnosys Vision Limited IE-AR-000002659
Sources (2)
- EUDAMED c8ccd037-1eaf-4d1a-a1ca-8d6ff75fdd25 61 fields · synced Jun 20, 2026
- FDA UDI eaa5e00b-c42d-47f7-b64b-90e983ecec7e 34 fields · synced May 30, 2026