Identity
- Trade Name
- NBS 6 EUDAMEDNexstim NBS System FDA UDI
- Generic Name
- Stereotactic neuronavigation/planning system FDA UDI
- Device Name
- Nexstim NBS System 6 EUDAMEDFDA UDI
- Model / Reference
- NX142433 EUDAMED6 FDA UDI
- Description
- Nexstim NBS System 6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430063200187 EUDAMEDFDA UDI
- Basic UDI-DI
- 643006320Nexstim100NBS6H4 EUDAMED
- Direct Marketing DI
- 06430063200187 EUDAMED
- 510(k) Number
- K182700 FDA UDI
- FDA Product Code
- GWF FDA UDIHAW FDA UDIIKN FDA UDIOBP FDA UDI
- EMDN Code
- Z12101106 NEUROLOGICAL STIMULATORS EUDAMED
- GMDN Term
- Stereotactic neuronavigation/planning system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1870 FDA UDI882.4560 FDA UDI890.1375 FDA UDI882.5805 FDA UDI
- Market of Registration
- Finland 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
Yes
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
No
FDA UDI
Nbs 6 by Nexstim Oyj — 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 | 643006320Nexstim100NBS6H4 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Nexstim Oyj
- EUDAMED SRN
- FI-MF-000006696
Sources (2)
- EUDAMED ba77693e-daf3-4bdf-bc02-8f7b6580cf18 61 fields · synced Jun 20, 2026
- FDA UDI 4c9d45ff-8e53-4389-8632-97c3c8253acf 35 fields · synced May 30, 2026