Identity
- Trade Name
- Disposable Stimulating Elevators EUDAMEDNeurosign V4 FDA UDI
- Generic Name
- Nerve-locating system probe, single-use FDA UDI
- Device Name
- Disposable Stimulation Probes and Surgical Instruments EUDAMEDDiposable Stimulating Elevator, 167mm stimulating electrode and 14mm x 0,38mm needle electrode FDA UDI
- Model / Reference
- 5875-00 EUDAMEDFDA UDI
- Description
- Diposable Stimulating Elevator, 167mm stimulating electrode and 14mm x 0,38mm needle electrode FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718375866061 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08718375866061 EUDAMED
- FDA Product Code
- ETN FDA UDI
- EMDN Code
- Z12101185 PERIPHERAL OR CENTRAL NEURO STIMULATION AND ASSESSMENT INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Nerve-locating system probe, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1820 FDA UDI
- Market of Registration
- Netherlands 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
Yes
FDA UDI
MR Unsafe FDA UDI
Disposable Stimulating Elevators by Technomed Europe — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-08718375866061 | 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
- Technomed Europe
- EUDAMED SRN
- NL-MF-000000064
Sources (2)
- EUDAMED d2ba7b99-d1c9-4363-80bb-92c26a0b2e99 61 fields · synced Aug 2, 2026
- FDA UDI 0e955620-877d-44e1-baf3-94a19cc3f356 34 fields · synced May 30, 2026