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Heidelberg OPERA
EUDAMEDClass I (EU MDR)
Ref V12404-01Model V10710-01, V12200-01, V12404-01
Identity
- Trade Name
- Heidelberg OPERA EUDAMED
- Device Name
- SeeLuma, Heidelberg OPERA EUDAMED
- Model / Reference
- V10710-01, V12200-01, V12404-01 EUDAMEDV12404-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04064434000216 EUDAMED
- Basic UDI-DI
- 4064434SeeLumaRZ EUDAMED
- Direct Marketing DI
- 04064434000216 EUDAMED
- EMDN Code
- Z12011101 OPERATIVE MICROSCOPES EUDAMED
Classification
- Device Class
- Class I 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
Heidelberg OPERA by Munich Surgical Imaging Gmbh — Class I — 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 | 4064434SeeLumaRZ | Class I | Active |
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Manufacturer
- Manufacturer
- Munich Surgical Imaging GmbH
- EUDAMED SRN
- DE-MF-000009644
Sources (1)
- EUDAMED 5491d39c-85c1-461c-aa64-13fe13ca2b9b 61 fields · synced Jun 20, 2026