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Mixed Reality Spine Navigation, 1.0
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 04056481143985
by Brainlab SE
Identity
- Trade Name
- Mixed Reality Spine Navigation, 1.0 EUDAMEDMixed Reality Spine Navigation FDA UDI
- Generic Name
- Electromagnetic/optical surgical navigation device tracking system FDA UDI
- Device Name
- Mixed Reality Spine Navigation EUDAMED
- Model / Reference
- 04056481143985 EUDAMED1.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481143985 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481MixedRealitySpMU EUDAMED
- Direct Marketing DI
- 04056481143985 EUDAMED
- 510(k) Number
- K242569 FDA UDI
- FDA Product Code
- SBF FDA UDI
- EMDN Code
- Z12011482 SURGICAL NAVIGATION INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Electromagnetic/optical surgical navigation device tracking system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 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
Mixed Reality Spine Navigation, 1.0 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 | 4056481MixedRealitySpMU | 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 39eb86c1-472d-4d66-885d-16b611702eb7 61 fields · synced Jul 24, 2026
- FDA UDI 2e50d0b0-2463-4270-8e5f-533fcd2869ba 33 fields · synced May 30, 2026