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Disposable Central Blade Nerve Monitoring Probe
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 5248-00
Identity
- Trade Name
- Disposable Central Blade Nerve Monitoring Probe EUDAMEDNeurosign V4 FDA UDI
- Generic Name
- Nerve-locating system probe, single-use FDA UDI
- Device Name
- Disposable Stimulation Probes and Surgical Instruments EUDAMEDDisposable Central Blade Nerve Monitoring Probe, 3mm Tip x 220mm electrode, 1,9m wire FDA UDI
- Model / Reference
- 5248-00 EUDAMEDFDA UDI
- Description
- Disposable Central Blade Nerve Monitoring Probe, 3mm Tip x 220mm electrode, 1,9m wire FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718375866078 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08718375866078 EUDAMED
- FDA Product Code
- GXZ 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
- 882.1350 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 Central Blade Nerve Monitoring Probe 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-08718375866078 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Technomed Europe
- EUDAMED SRN
- NL-MF-000000064
Sources (2)
- EUDAMED e9bb22e6-8c0d-4c6a-8b0f-2e853687ec96 61 fields · synced Jul 9, 2026
- FDA UDI 80608289-e4cc-415c-8d90-014ee47e8c68 34 fields · synced May 30, 2026