Identity
- Trade Name
- Patient Reference FDA UDI
- Generic Name
- Robotic surgical navigation system FDA UDI
- Device Name
- Patient reference EUDAMEDThe Patient Reference is an instrument of the EPIONE device used to track the patient position and motions including breathing. FDA UDI
- Model / Reference
- 02-0026 EUDAMEDFDA UDI
- Description
- The Patient Reference is an instrument of the EPIONE device used to track the patient position and motions including breathing. FDA UDI
Identifiers
- Catalog Number
- 02-0026 FDA UDI
- Primary DI / UDI-DI
- 03760305400024 EUDAMEDFDA UDI
- Basic UDI-DI
- 37603054002PRYG EUDAMED
- Direct Marketing DI
- 03760305400024 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
- 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
Patient reference 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 | 37603054002PRYG | 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 (3)
- EUDAMED b40cfc39-c20c-48ef-8f0e-6ae37e6f3b92 61 fields · synced Jun 18, 2026
- FDA UDI b5b1a2c6-1b87-4cfe-b45f-5b9d96bd8f45 34 fields · synced May 30, 2026
- EUDAMED 5e74fde3-a71a-4e73-8894-f805767c1785 61 fields · synced Jun 18, 2026