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Alignment Software Cranial, 2.1
EUDAMEDClass IIb (EU MDR)
Ref 04056481146313
by Brainlab SE
Identity
- Trade Name
- Alignment Software Cranial, 2.1 EUDAMED
- Device Name
- Alignment Software Cranial EUDAMED
- Model / Reference
- 04056481146313 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056481146313 EUDAMED
- Basic UDI-DI
- 4056481AlignmentCranialBM EUDAMED
- Direct Marketing DI
- 04056481146313 EUDAMED
- EMDN Code
- Z12011492 SURGICAL NAVIGATION INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Alignment Software Cranial, 2.1 by Brainlab SE — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4056481AlignmentCranialBM | Class IIb | Active |
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Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (1)
- EUDAMED dacec49a-0e35-453a-bf0b-e0f9620523db 61 fields · synced Jul 15, 2026