Kick 2 Navigation Station EM, Kick® Navigation, Kick2® Navigation, Kick Navigat…
EUDAMEDFDA UDIClass IIb (EU MDR)
by Brainlab SE
Identity
- Trade Name
- Kick 2 Navigation Station EM, Kick® Navigation, Kick2® Navigation, Kick Navigation EM, Kick Navigation System EM EUDAMEDKick 2 Navigation Station EM FDA UDI
- Generic Name
- Electromagnetic/optical surgical navigation device tracking system FDA UDI
- Device Name
- Kick 2 Navigation Station EUDAMEDThe platform hosts one or more Brainlab Software Applications. It incorporates a computer and display unit to facilitate the display, exchange, processing and interaction with data and tracking for Imaged Guided Surgery (IGS) purposes. FDA UDI
- Model / Reference
- 18202 EUDAMEDFDA UDI
- Description
- The platform hosts one or more Brainlab Software Applications. It incorporates a computer and display unit to facilitate the display, exchange, processing and interaction with data and tracking for Imaged Guided Surgery (IGS) purposes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481143725 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481Kick99 EUDAMED
- FDA Product Code
- HAW FDA UDIPGW 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
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
Kick 2 Navigation Station EM, Kick® Navigation, Kick2® Navigation, Kick Navigat… by Brainlab SE — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 | 4056481Kick99 | 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 da7d0a0e-1dad-44b6-8438-4366233b90b5 61 fields · synced Jul 23, 2026
- FDA UDI bfcd0878-1e05-4a49-9ef1-aa3c950dea35 34 fields · synced May 30, 2026