Identity
- Trade Name
- Assure Plus EUDAMED
- Device Name
- Assure Plus EUDAMED
- Model / Reference
- Assure Plus 1.0.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860011973201 EUDAMED
- Basic UDI-DI
- 08600119732APVN EUDAMED
- EMDN Code
- Z12120192 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Assure Plus by Eyetelligence Pty Ltd, an Optain Health Company — 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 | 08600119732APVN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Eyetelligence Pty Ltd, an Optain Health Company
- EUDAMED SRN
- AU-MF-000044109
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED e49b77cd-421e-4125-94c2-c0d33554698a 61 fields · synced Jun 18, 2026