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Brainlab Elements Image Fusion, 4.5
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 04056481143992
by Brainlab SE
Identity
- Trade Name
- Brainlab Elements Image Fusion, 4.5 EUDAMEDBrainlab Elements Image Fusion FDA UDI
- Generic Name
- Stereotactic system application software FDA UDI
- Device Name
- Brainlab Elements Image Fusion EUDAMED
- Model / Reference
- 04056481143992 EUDAMED4.5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481143992 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481FusionP4 EUDAMED
- Direct Marketing DI
- 04056481143992 EUDAMED
- 510(k) Number
- K223106 FDA UDI
- FDA Product Code
- QIH FDA UDIJAK FDA UDILLZ FDA UDI
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Stereotactic system application software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI892.1750 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
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
Brainlab Elements Image Fusion, 4.5 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 | 4056481FusionP4 | 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 50dbd8f8-3109-4199-ba12-987c9fd951eb 61 fields · synced Jun 20, 2026
- FDA UDI dc09b243-1185-4035-8281-8b78366c9d27 33 fields · synced May 30, 2026