Identity
- Trade Name
- OPTRA-SAFE EUDAMED
- Device Name
- Sodium Chloride Eyewash Solution 0.9% w/v - 15 ml EUDAMED
- Model / Reference
- 124 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-124salinesolutionTL EUDAMED
- Basic UDI-DI
- B-124salinesolutionTL EUDAMED
- EMDN Code
- Q02030299 OPHTHALMOLOGY, LIQUID FLUIDS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Optra-Safe by Legency Remedies Pvt. Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-124salinesolutionTL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Legency Remedies Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000010030
- Authorised Representative
- Europecert UG (haftungsbeschränkt) DE-AR-000004974
Sources (1)
- EUDAMED fcddc29b-2b7f-434a-bec0-c3fb670113a8 61 fields · synced Jul 29, 2026