Identity
- Trade Name
- Standalone EUDAMEDFDA UDI
- Generic Name
- Electroretinograph FDA UDI
- Device Name
- Standalone EUDAMEDStandalone is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). FDA UDI
- Model / Reference
- D175 EUDAMEDFDA UDI
- Description
- Standalone is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850594007004 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00850594007004 EUDAMED
- 510(k) Number
- K863956 FDA UDI
- FDA Product Code
- GWE FDA UDI
- EMDN Code
- Z1212012001 VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT EUDAMED
- GMDN Term
- Electroretinograph FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1890 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Standalone 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-00850594007004 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diagnosys LLC
- EUDAMED SRN
- US-MF-000002934
- Authorised Representative
- Diagnosys Vision Limited IE-AR-000002659
Sources (2)
- EUDAMED 7d5225a2-9745-4a71-8e54-d1fe82ed3335 61 fields · synced Jun 17, 2026
- FDA UDI 65283248-4932-46b6-a0f5-00354a481837 35 fields · synced May 29, 2026