Identity
- Trade Name
- NexSpeech EUDAMEDNexSpeech main software FDA UDI
- Generic Name
- Stereotactic neuronavigation/planning system FDA UDI
- Device Name
- NexSpeech EUDAMEDNexSpeech Main Software FDA UDI
- Model / Reference
- NX92527 EUDAMED2 FDA UDI
- Description
- NexSpeech Main Software FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430063200026 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06430063200026 EUDAMED
- 510(k) Number
- K112881 FDA UDI
- FDA Product Code
- IKN FDA UDIGWF FDA UDIHAW 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
- 890.1375 FDA UDI882.1870 FDA UDI882.4560 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Point aesthesiometer
NexSpeech by Nexstim Oyj — Class IIa — MDD, 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/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06430063200026 | 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 2daf7ee9-a1e0-4a18-91a9-43e34d53456f 61 fields · synced Aug 2, 2026
- FDA UDI d3083f18-cf7b-49c6-b096-3a4be5cd9665 35 fields · synced May 25, 2026