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Ultrasound Navigation Adapter (bk X18l5s)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 41860-43Model 41860-42
by Brainlab SE
Identity
- Trade Name
- ULTRASOUND NAVIGATION ADAPTER (BK X18L5S) EUDAMEDAdapter BK-9009 FDA UDI
- Generic Name
- Robotic surgical navigation system FDA UDI
- Device Name
- ULTRASOUND NAVIGATION ADAPTER GENERIC EUDAMED
- Model / Reference
- 41860-42 EUDAMED41860-43 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481140854 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481USNavAdapter9Y EUDAMED
- Direct Marketing DI
- 04056481140854 EUDAMED
- FDA Product Code
- HAW FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Robotic surgical navigation system 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Ultrasound Navigation Adapter (bk X18l5s) by Brainlab SE — Class I — 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 | 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 1e18f7ed-5b10-42ac-b191-c94acd67ef42 61 fields · synced Jun 18, 2026
- FDA UDI 8d86f8a4-5fee-4613-b88d-b6cf89b91d35 34 fields · synced May 30, 2026