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Alignment Software Cranial, 2.0
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 04056481144487
by Brainlab SE
Identity
- Trade Name
- Alignment Software Cranial, 2.0 EUDAMEDAlignment Software Cranial FDA UDI
- Generic Name
- Electromagnetic/optical surgical navigation device tracking system FDA UDI
- Device Name
- Alignment Software Cranial EUDAMEDThe Alignment Software Cranial is a software which enables navigated surgery. It is intended to support the surgeon in planning and reaching a pre-defined position through manual or semi-automated navigation of surgical instruments based on information obtained from optical tracking devices. FDA UDI
- Model / Reference
- 04056481144487 EUDAMED2.0 FDA UDI
- Description
- The Alignment Software Cranial is a software which enables navigated surgery. It is intended to support the surgeon in planning and reaching a pre-defined position through manual or semi-automated navigation of surgical instruments based on information obtained from optical tracking devices. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481144487 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481AlignmentCranialBM EUDAMED
- Direct Marketing DI
- 04056481144487 EUDAMED
- 510(k) Number
- K223864 FDA UDI
- FDA Product Code
- HAW FDA UDI
- EMDN Code
- Z12011492 SURGICAL NAVIGATION INSTRUMENTS - MEDICAL DEVICE SOFTWARE 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
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
Alignment Software Cranial, 2.0 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 | 4056481AlignmentCranialBM | 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 b3c358c6-0024-437b-b61f-ea6d55e5e5f1 61 fields · synced Jun 19, 2026
- FDA UDI bde95214-df67-4421-9ce8-bdb905f56569 34 fields · synced May 30, 2026