Identity
- Trade Name
- VisionOne EUDAMED
- Device Name
- Perimetry device EUDAMED
- Model / Reference
- 016.001.001, 016.001.002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640255020663 EUDAMED
- Basic UDI-DI
- 764025502TD01648 EUDAMED
- EMDN Code
- Z1212012092 INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
VisionOne by Effectum Medical AG — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764025502TD01648 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Effectum Medical AG
- EUDAMED SRN
- CH-MF-000012474
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED e62e283f-9306-4a7b-8aa0-21b31c7dcd8b 61 fields · synced Jun 18, 2026
- EUDAMED e62e283f-9306-4a7b-8aa0-21b31c7dcd8b-1 61 fields · synced Jun 10, 2026