Identity
- Trade Name
- LUNA 3D Central Server Software EUDAMEDLUNA 3D FDA UDI
- Generic Name
- Radiological video camera patient positioning/tracking system FDA UDI
- Device Name
- LUNA 3D EUDAMED
- Model / Reference
- 0018440 EUDAMEDLUNA 3D Central Server Software FDA UDI
Identifiers
- Catalog Number
- 0018440 FDA UDI
- Primary DI / UDI-DI
- 04260590372628 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 Central Server Software by LAP GmbH Laser Applikationen — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426059037SGRTD3 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- LAP GmbH Laser Applikationen
- EUDAMED SRN
- DE-MF-000005792
Sources (2)
- EUDAMED 212529ae-e697-4cc4-8371-a7a1fa2db049 61 fields · synced Jul 28, 2026
- FDA UDI 6d4d37e6-59de-435c-a3e1-120a109489a5 34 fields · synced May 30, 2026