Alignment Bone Anchor Cranial 2.1/3.8
EUDAMEDFDA UDIClass IIa (EU MDR)
by Brainlab SE
Identity
- Trade Name
- Alignment Bone Anchor Cranial 2.1/3.8 EUDAMEDFDA UDI
- Generic Name
- Electromagnetic/optical surgical navigation device tracking system FDA UDI
- Device Name
- Alignment Bone Anchor EUDAMED
- Model / Reference
- 56424 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481143817 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481BoneAnchor35 EUDAMED
- Direct Marketing DI
- 04056481143817 EUDAMED
- FDA Product Code
- HAW FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electromagnetic/optical surgical navigation device tracking system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
Yes
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Neurological stereotactic surgery system
Alignment Bone Anchor Cranial 2.1/3.8 by Brainlab SE — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4056481BoneAnchor35 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (2)
- EUDAMED 756dce35-41a5-4237-bf83-192c421ba175 61 fields · synced Jun 19, 2026
- FDA UDI 063723ae-41ff-4131-a90e-9b9bd1e7f083 33 fields · synced May 29, 2026