Identity
- Trade Name
- SOCT EUDAMED
- Device Name
- SOCT EUDAMED
- Model / Reference
- 21.5.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903293141014 EUDAMED
- Basic UDI-DI
- 590329314100SOCTQ4 EUDAMED
- Direct Marketing DI
- 05903293141014 EUDAMED
- EMDN Code
- Z12120182 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Poland 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
Soct by Optopol Technology Sp Z O O — 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 | 590329314100SOCTQ4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- OPTOPOL Technology Sp. z o.o.
- EUDAMED SRN
- PL-MF-000004770
Sources (1)
- EUDAMED b4b647dc-52b7-47a0-898d-b2db41460138 61 fields · synced Jun 18, 2026