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RT Elements - Cranial SRS w/ Cones, 3.0
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 04056481000530
by Brainlab SE
Identity
- Trade Name
- RT Elements - Cranial SRS w/ Cones, 3.0 EUDAMEDRT Elements - Cranial SRS w/ Cones FDA UDI
- Generic Name
- Radiation therapy software FDA UDI
- Device Name
- RT Elements EUDAMED
- Model / Reference
- 04056481000530 EUDAMED3.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481000530 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04056481000530 EUDAMED
- 510(k) Number
- K203681 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
- -1192 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
RT Elements - Cranial SRS w/ Cones, 3.0 by Brainlab SE — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04056481000530 | 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 79d15655-0a46-49ec-ab51-0f9e79e3bdfd 61 fields · synced Jun 19, 2026
- FDA UDI 14bd90eb-d480-4700-a23c-1b4cccd2fbd8 33 fields · synced May 30, 2026