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SeeLuma
EUDAMEDClass I (EU MDR)
Ref V12200-01Model V10710-01, V12200-01, V12404-01Ref V10710-01
Identity
- Trade Name
- SeeLuma EUDAMED
- Device Name
- SeeLuma, Heidelberg OPERA EUDAMED
- Model / Reference
- V10710-01, V12200-01, V12404-01 EUDAMEDV12200-01 EUDAMEDV10710-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04064434000131 EUDAMED04064434000049 EUDAMED
- Basic UDI-DI
- 4064434SeeLumaRZ EUDAMED
- Direct Marketing DI
- 04064434000131 EUDAMED04064434000049 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
SeeLuma 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 (2)
- EUDAMED 335e5b22-322b-48a7-bd6a-14185411efe2 61 fields · synced Jul 18, 2026
- EUDAMED 81f20889-0617-41ad-a796-706e1f125f0e 61 fields · synced May 17, 2026