Identity
- Trade Name
- iOCT Module EUDAMED
- Device Name
- iOCT Module EUDAMED
- Model / Reference
- V12400-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04064434000179 EUDAMED
- Basic UDI-DI
- 4064434SeeLumaiOCTBT EUDAMED
- EMDN Code
- Z12120121 OPTICAL CONSISTENCY TOMOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
iOCT Module by Munich Surgical Imaging 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 | 4064434SeeLumaiOCTBT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Munich Surgical Imaging GmbH
- EUDAMED SRN
- DE-MF-000009644
Sources (1)
- EUDAMED 9b8b1944-a993-4ea3-a6d7-c9ebebb3cd21 61 fields · synced Jul 9, 2026