Identity
- Trade Name
- Navient EUDAMEDNaviENT system with Kit FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- Navient Image Guided Navigation System EUDAMEDNavient ENT system with kit FDA UDI
- Model / Reference
- 955-NE-NE EUDAMEDFDA UDI
- Description
- Navient ENT system with kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540209955112 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07540209955112 EUDAMED
- 510(k) Number
- K163439 FDA UDI
- FDA Product Code
- HAW FDA UDI
- EMDN Code
- Z12011401 SURGICAL NAVIGATION SYSTEM EUDAMED
- GMDN Term
- Neurological stereotactic surgery system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- France 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Navient by Claronav Kolahi — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07540209955112 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Claronav Kolahi
- EUDAMED SRN
- CA-MF-000037841
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 442cbb0d-7b1a-4f57-a64e-0386e1c2d8b3 61 fields · synced Aug 3, 2026
- FDA UDI 7217eed2-f7e0-4e40-a4ae-e80573f2b048 35 fields · synced May 25, 2026