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RT Elements, 4.0
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 04056481144494
by Brainlab SE
Identity
- Trade Name
- RT Elements, 4.0 EUDAMEDRT Elements FDA UDI
- Generic Name
- Radiation therapy software FDA UDI
- Device Name
- RT Elements EUDAMED
- Model / Reference
- 04056481144494 EUDAMED4.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481144494 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481RTElementsW8 EUDAMED
- Direct Marketing DI
- 04056481144494 EUDAMED
- 510(k) Number
- K223279 FDA UDI
- FDA Product Code
- MUJ FDA UDI
- EMDN Code
- Z11010492 RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiation therapy software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Special Device Type
- Software EUDAMED
- 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
RT Elements, 4.0 by Brainlab SE — 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 | 4056481RTElementsW8 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (2)
- EUDAMED 8136d705-7e18-454e-a149-c0f70951891c 61 fields · synced Jul 9, 2026
- FDA UDI 10e2a9ea-9028-4061-a260-56d3bf33d11e 33 fields · synced May 29, 2026