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NICO BrainPath
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref NN-8026Model NICO BrainPath
Identity
- Trade Name
- NICO BrainPath EUDAMEDFDA UDI
- Generic Name
- Neurosurgical retraction cannula stabilization tool FDA UDI
- Device Name
- Shepherd's Hook EUDAMEDShepherd's Hook Budde FDA UDI
- Model / Reference
- NICO BrainPath EUDAMEDNN-8026 EUDAMEDFDA UDI
- Description
- Shepherd's Hook Budde FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816744028268 EUDAMEDFDA UDI
- Basic UDI-DI
- 081674402BP4DG EUDAMED
- FDA Product Code
- GDG FDA UDI
- EMDN Code
- Z12109099 VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Neurosurgical retraction cannula stabilization tool FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
NICO BrainPath by NICO Corporation — Class IIa — 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 | 081674402BP4DG | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- NICO Corporation
- EUDAMED SRN
- US-MF-000000769
- Authorised Representative
- Atlantico Systems, Ltd. IE-AR-000000208
Sources (2)
- EUDAMED ac58028f-a1a5-4da2-879e-b88db89c592d 61 fields · synced Jul 17, 2026
- FDA UDI 7ebf087a-40a1-4021-9b73-f88940f4a0ed 34 fields · synced May 30, 2026