← Back to catalogue
Navigation Set SPX1, Targeting Needle Bevel Tip – 11G, 125mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref A00019
Identity
- Trade Name
- Navigation Set SPX1, Targeting Needle Bevel Tip - 11G, 125mm FDA UDI
- Generic Name
- Stereotactic surgery system probe, single-use FDA UDI
- Device Name
- Navigation Set SPX1, Targeting Needle Bevel Tip – 11G, 125mm EUDAMED
- Model / Reference
- A00019 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701311500070 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03701311500070 EUDAMED
- 510(k) Number
- K221028 FDA UDI
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z12130485 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Stereotactic surgery system probe, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Navigation Set SPX1, Targeting Needle Bevel Tip – 11G, 125mm by Ecential Robotics — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-03701311500070 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ecential Robotics
- EUDAMED SRN
- FR-MF-000003577
Sources (2)
- EUDAMED 6c178dfd-e95e-4ed7-b068-f0d9f6a7db72 61 fields · synced Jun 18, 2026
- FDA UDI 639d5bdf-0460-4044-9987-f33314edfbac 35 fields · synced May 26, 2026