Identity
- Trade Name
- Optima Gold EUDAMED
- Device Name
- PMMA Intraocular Lens EUDAMED
- Model / Reference
- MCS 603H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904211453742 EUDAMED
- Basic UDI-DI
- 89042114PMMARG EUDAMED
- Direct Marketing DI
- 08904211453742 EUDAMED
- EMDN Code
- P030102090299 IOLs, APHAKIC, MONOFOCAL, ASPHERIC - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Optima Gold by Excellent Hi -Care Private Limited — 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 | 89042114PMMARG | 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 eb3ad1fc-eeba-4e46-b539-d0ee10c45ff1 61 fields · synced Jun 18, 2026