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Disposable Bipolar Probe
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SO-SB01Ref 3604-00-TE
Identity
- Trade Name
- Disposable Bipolar Probe EUDAMEDDisposable Bipolar Probe, Precision EUDAMEDNeurosign V4 FDA UDI
- Generic Name
- Nerve-locating system probe, single-use FDA UDI
- Device Name
- Disposable Stimulation Probes and Surgical Instruments EUDAMEDDisposable Bipolar Probe; Precision 2 x 70mm x 0.75mm electrodes; 1.9m twisted wire with DIN42802 connectors, blue wire is active FDA UDI
- Model / Reference
- SO-SB01 EUDAMED3604-00-TE EUDAMEDFDA UDI
- Description
- Disposable Bipolar Probe; Precision 2 x 70mm x 0.75mm electrodes; 1.9m twisted wire with DIN42802 connectors, blue wire is active FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718375868966 EUDAMED08718375865019 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08718375868966 EUDAMEDB-08718375865019 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 Bipolar 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-08718375868966 | 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 (3)
- EUDAMED c01769b1-679a-4e4a-9fdc-c75c8a6029cc 61 fields · synced Jul 13, 2026
- EUDAMED a8470942-7eaf-4db0-ae09-455bc46ddf2f 61 fields · synced May 18, 2026
- FDA UDI 3262bb77-12d6-4750-b1e2-7682d96d0cef 34 fields · synced May 27, 2026