Identity
- Trade Name
- SOCT EUDAMED
- Device Name
- SOCT Software EUDAMEDSOCT EUDAMED
- Model / Reference
- SOCT Software EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903293141342 EUDAMED05903293141496 EUDAMED05903293141410 EUDAMED
- Basic UDI-DI
- B-05903293141342 EUDAMED590329314100SOCTQ4 EUDAMED
- Direct Marketing DI
- 05903293141496 EUDAMED05903293141410 EUDAMED
- EMDN Code
- Z12120182 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMEDSoftware 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, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-05903293141342 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-05903293141342 | Class IIa | Active |
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Manufacturer
- Manufacturer
- OPTOPOL Technology Sp. z o.o.
- EUDAMED SRN
- PL-MF-000004770
Sources (3)
- EUDAMED a655a42b-c1af-4b6d-915d-2e0b974a78c0 61 fields · synced Jul 28, 2026
- EUDAMED d5baafa3-53db-4236-8398-d87bbb8172fe 61 fields · synced May 18, 2026
- EUDAMED ed52931d-1c8b-4d07-808b-6e6af5d6053b 61 fields · synced May 18, 2026