Ultrasound Navigation Adapter (bk N13c5)
EUDAMEDFDA UDIClass I (EU MDR)
by Brainlab SE
Identity
- Trade Name
- ULTRASOUND NAVIGATION ADAPTER (BK N13C5) EUDAMEDFDA UDI
- Generic Name
- Neurosurgical ultrasound navigation system optical tracking unit FDA UDI
- Device Name
- ULTRASOUND NAVIGATION ADAPTER GENERIC EUDAMED
- Model / Reference
- 41860-42 EUDAMED41860-40A EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481144173 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481USNavAdapter9Y EUDAMED
- Direct Marketing DI
- 04056481144173 EUDAMED
- 510(k) Number
- K192703 FDA UDI
- FDA Product Code
- HAW FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Neurosurgical ultrasound navigation system optical tracking unit FDA UDI
Classification
- Device Class
- Class I 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
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
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
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Neurological stereotactic surgery system
Ultrasound Navigation Adapter (bk N13c5) by Brainlab SE — Class I — 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 | 4056481USNavAdapter9Y | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (2)
- EUDAMED 22798e06-9da7-46cb-ade6-f5f69f456ad2 61 fields · synced Jul 10, 2026
- FDA UDI 2912ad75-f8fc-41f4-8152-5673fe2056b9 33 fields · synced May 30, 2026