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LUNA 3D Workstation Software
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 0018438
Identity
- Trade Name
- LUNA 3D Workstation Software EUDAMEDLUNA 3D FDA UDI
- Generic Name
- Radiological video camera patient positioning/tracking system FDA UDI
- Device Name
- LUNA 3D EUDAMED
- Model / Reference
- 0018438 EUDAMEDLUNA 3D Workstation Software FDA UDI
Identifiers
- Catalog Number
- 0018438 FDA UDI
- Primary DI / UDI-DI
- 04260590372611 EUDAMEDFDA UDI
- Basic UDI-DI
- 426059037SGRTD3 EUDAMED
- 510(k) Number
- K232031 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z119099 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Radiological video camera patient positioning/tracking system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
LUNA 3D Workstation Software by LAP GmbH Laser Applikationen — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232031 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 426059037SGRTD3 | Class IIb | Active |
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Manufacturer
- Manufacturer
- LAP GmbH Laser Applikationen
- EUDAMED SRN
- DE-MF-000005792
Sources (3)
- EUDAMED 7bc976d9-357a-4f15-a974-f78c6e74370b 61 fields · synced Jul 18, 2026
- FDA UDI a16b7cf4-f7a0-4e4c-8747-c6d8f366edaa 34 fields · synced May 30, 2026
- FDA 510(k) K232031 1 fields · synced May 18, 2026