Identity
- Trade Name
- IVOM-OP-Set EUDAMED
- Device Name
- Katarakt-Set EUDAMED
- Model / Reference
- 66231430-03 EUDAMED66227815-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04034393703817 EUDAMED
- Basic UDI-DI
- 4034393CPTOPH2A2R EUDAMED
- EMDN Code
- A010599 OPHTHALMOLOGY INJECTION NEEDLES AND KITS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Sterile, disposable procedure pack, combination of devices for disease treatment or modification of the anatomy related to ophthalmology. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
IVOM-OP-Set by Sengewald Klinikprodukte GmbH — Class IIa — 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 | 4034393CPTOPH2A2R | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sengewald Klinikprodukte GmbH
- EUDAMED SRN
- DE-PR-000020748
Sources (1)
- EUDAMED 06676539-50fe-4eb1-8701-69a8cc651ef8 61 fields · synced Sep 18, 2026