Identity
- Trade Name
- OPTIREL EUDAMED
- Device Name
- LENS CARE EUDAMED
- Model / Reference
- 380 ml, 100 ml EUDAMEDOR-380 EUDAMEDOR-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03859893939389 EUDAMED03859893939396 EUDAMED
- Basic UDI-DI
- 8606100346LENS444careM4 EUDAMED
- EMDN Code
- Q02030204 CONTACT LENSES STORING AND CLEANING SOLUTIONS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Croatia EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Optirel by Pharma Product Doo — Class IIb — 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 | 8606100346LENS444careM4 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Pharma Product Doo
- EUDAMED SRN
- RS-MF-000024163
- Authorised Representative
- TNMC Devices Llc HR-AR-000019582
Sources (2)
- EUDAMED 158a05ea-53c5-4aeb-9dde-705687f86942 61 fields · synced Jul 24, 2026
- EUDAMED f62e13be-7a02-4fa1-86e2-021b3e73bf38 61 fields · synced May 17, 2026