Identity
- Trade Name
- Navigation probe FDA UDI
- Generic Name
- Robotic surgical navigation system FDA UDI
- Device Name
- Navigation probe EUDAMEDThe Navigation Probe is an instrument of the EPIONE device. It enables visualizing reference points or anatomical landmarks in the medical images. It allows the verification of patient registration accuracy, using external anatomical landmarks or skin markers. FDA UDI
- Model / Reference
- 02-0031 EUDAMEDFDA UDI
- Description
- The Navigation Probe is an instrument of the EPIONE device. It enables visualizing reference points or anatomical landmarks in the medical images. It allows the verification of patient registration accuracy, using external anatomical landmarks or skin markers. FDA UDI
Identifiers
- Catalog Number
- 02-0031 FDA UDI
- Primary DI / UDI-DI
- 03760305400055 EUDAMEDFDA UDI
- Basic UDI-DI
- 37603054002NPY6 EUDAMED
- Direct Marketing DI
- 03760305400055 EUDAMED
- FDA Product Code
- JAK 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
- 892.1750 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- Not 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
Moist Heat or Steam Sterilization FDA UDI
Category: Neurological stereotactic surgery system
Navigation probe by Quantum Surgical SAS — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 37603054002NPY6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Quantum Surgical SAS
- EUDAMED SRN
- FR-MF-000000600
Sources (2)
- EUDAMED a366331a-ecfb-468b-8f98-992f9d1fafd1 61 fields · synced Jun 18, 2026
- FDA UDI e27efc93-5caa-41a2-9dcb-57c6e4ebd0a1 35 fields · synced May 30, 2026