Identity
- Trade Name
- Universal Tracker for Biopsy EUDAMEDUniversal Tracker Biopsy FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- Disposable Instruments EUDAMEDUniversal Tracker Biopsy for use with Navient system, cranial FDA UDI
- Model / Reference
- 950-NC-UTB EUDAMEDFDA UDI
- Description
- Universal Tracker Biopsy for use with Navient system, cranial FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540209955723 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540209955-NC-DINSTQM EUDAMED
- 510(k) Number
- K241327 FDA UDI
- FDA Product Code
- HAW FDA UDI
- EMDN Code
- Z12011485 SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Neurological stereotactic surgery system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Greece EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Universal Tracker for Biopsy by Claronav Kolahi — 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 | 7540209955-NC-DINSTQM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 520d8d5a-ac82-437f-a402-8df0c7a90921 61 fields · synced Jul 13, 2026
- FDA UDI 8e4291a8-0766-42dc-abbc-6fbb6a938419 34 fields · synced May 30, 2026