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Buzz Navigation (Ceiling-Mounted)
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 15706
by Brainlab SE
Identity
- Trade Name
- Buzz Navigation (Ceiling-Mounted) EUDAMEDBuzz Navigation (Ceiling Mounted) FDA UDI
- Generic Name
- Electromagnetic/optical surgical navigation device tracking system FDA UDI
- Device Name
- Buzz Navigation (Ceiling-Mounted) EUDAMED
- Model / Reference
- 15706 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 15706 FDA UDI
- Primary DI / UDI-DI
- 04056481140847 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481BuzzNavigationE3 EUDAMED
- 510(k) Number
- K092467 FDA UDIK183605 FDA UDIK221618 FDA UDIK223288 FDA UDIK223864 FDA UDIK243698 FDA UDI
- FDA Product Code
- HAW FDA UDIOLO 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 IIb 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
Yes
FDA UDI
Buzz Navigation (Ceiling-Mounted) 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 | 4056481BuzzNavigationE3 | 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 1a94f165-6998-41e0-b4fd-0defb25ff7c5 61 fields · synced Jul 15, 2026
- FDA UDI d90de9f8-ee51-4365-a06e-f6fe1637d233 35 fields · synced May 30, 2026