Navigation Probe Adapter
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- NICO BrainPath FDA UDI
- Generic Name
- Neurosurgical retraction obturator/probe adaptor FDA UDI
- Device Name
- Navigation Probe Adapter EUDAMEDFDA UDI
- Model / Reference
- NICO BrainPath EUDAMEDNN-8045 EUDAMEDFDA UDI
- Description
- Navigation Probe Adapter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816744028459 EUDAMEDFDA UDI
- Basic UDI-DI
- 081674402BP5DJ EUDAMED
- FDA Product Code
- GZT FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Neurosurgical retraction obturator/probe adaptor FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Neurological stereotactic surgery system
Navigation Probe Adapter by NICO Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081674402BP5DJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 70d37d47-bcd9-4b6d-b71e-72065882c0d2 61 fields · synced Jul 21, 2026
- FDA UDI 2e1a193b-5c91-4523-8c93-7c2c36ef8fa3 34 fields · synced May 29, 2026