← Back to catalogue
ExacTrac Dynamic, 1.1
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 48519A
by Brainlab SE
Identity
- Trade Name
- ExacTrac Dynamic, 1.1 EUDAMEDExacTrac Dynamic FDA UDI
- Generic Name
- Radiation therapy software FDA UDI
- Device Name
- ExacTrac Dynamic EUDAMED
- Model / Reference
- 48519A EUDAMED1.1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481143978 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481ExacTracEU EUDAMED
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11019099 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Radiation therapy software 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ExacTrac Dynamic, 1.1 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 | 4056481ExacTracEU | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (2)
- EUDAMED 5ce0540e-2db9-4bb6-bf5c-a92204b83f67 61 fields · synced Jul 14, 2026
- FDA UDI db4965fd-4d26-4313-b531-c9fa4b7143f7 33 fields · synced May 30, 2026