Identity
- Trade Name
- Optima Gold EUDAMED
- Device Name
- PMMA Intraocular lens EUDAMED
- Model / Reference
- MCS 603 HSQY EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904211465868 EUDAMED
- Basic UDI-DI
- B-08904211465868 EUDAMED
- EMDN Code
- P030102090299 IOLs, APHAKIC, MONOFOCAL, ASPHERIC - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Optima Gold by Excellent Hi -Care Private Limited — Class IIb — 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-08904211465868 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Excellent Hi -Care Private Limited
- EUDAMED SRN
- IN-MF-000018641
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 1aefc42b-2240-46c1-8188-c3b4bc6dac66 61 fields · synced Jun 18, 2026