Identity
- Trade Name
- MaculoScope EUDAMED
- Device Name
- MaculoScope EUDAMED
- Model / Reference
- D130 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00855730007412 EUDAMED
- Basic UDI-DI
- B-00855730007412 EUDAMED
- EMDN Code
- Z1212012001 VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
MaculoScope by Diagnosys Llc — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00855730007412 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Diagnosys LLC
- EUDAMED SRN
- US-MF-000002934
- Authorised Representative
- Diagnosys Vision Limited IE-AR-000002659
Sources (1)
- EUDAMED 679f7bc0-d5dd-4880-8be2-f61aee030ae6 61 fields · synced Jul 11, 2026