Identity
- Trade Name
- LUNA Distribution Box EUDAMEDLUNA 3D FDA UDI
- Generic Name
- Radiological video camera patient positioning/tracking system FDA UDI
- Device Name
- LUNA 3D EUDAMED
- Model / Reference
- 0018364-0009 EUDAMEDLUNA Distribution Box FDA UDI
Identifiers
- Catalog Number
- 0018364-0009 FDA UDI
- Primary DI / UDI-DI
- 04260590372598 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 Distribution Box 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 06647660-216b-49d3-8a0d-785f6d720831 61 fields · synced Jul 22, 2026
- FDA UDI 5c57e965-f345-446e-bd2a-e4c877dff3f3 34 fields · synced May 30, 2026