Identity
- Device Name
- Lumina 3D EUDAMED
- Model / Reference
- Lumina 3D v1.x EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B761RN3D1X0/$RN3D1.0.0.0/16D20250212O EUDAMED
- Basic UDI-DI
- ++B761LUMINA3D9B EUDAMED
- Direct Marketing DI
- +B761RN3D1X0/$RN3D1.0.0.0/16D20250212O EUDAMED
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software 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
Lumina 3D by iSchemaView, Inc. — 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 | ++B761LUMINA3D9B | Class IIb | Active |
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Manufacturer
- Manufacturer
- iSchemaView, Inc.
- EUDAMED SRN
- US-MF-000040716
- Authorised Representative
- TSQ Global Srl IT-AR-000008109
Sources (1)
- EUDAMED e3638f65-f662-40de-8436-8e1a498c80fa 61 fields · synced Jul 31, 2026