Identity
- Trade Name
- Polarized Viewer - Infant EUDAMED
- Device Name
- Stereotest viewer EUDAMED
- Model / Reference
- SO013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03615020000885 EUDAMED
- Basic UDI-DI
- 361502000000IPOLARIZEDVMN EUDAMED
- EMDN Code
- Z1212012080 INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Polarized Viewer - Infant by Essilor International — Class I — 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 | 361502000000IPOLARIZEDVMN | Class I | Active |
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Manufacturer
- Manufacturer
- Essilor International
- EUDAMED SRN
- FR-MF-000007175
Sources (1)
- EUDAMED 7ddd2a33-7719-451a-b124-b2c3b74c7cf5 61 fields · synced Jun 19, 2026