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Disposable Stimulation Probe - Disposable Ball Tip Probe
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BTP2.3-130/10Ref BTP3.0-100/10
Identity
- Trade Name
- Disposable Stimulation Probe - Disposable Ball Tip Probe EUDAMEDTechnomed Europe FDA UDI
- Generic Name
- Nerve-locating system probe, single-use FDA UDI
- Device Name
- Disposable Stimulation Probes and Surgical Instruments EUDAMEDDisposable Stimulation Probe Disposable Ball Tip Probe 3mm ball; 100mm x 2.2mm electrode FDA UDIDisposable Stimulation Probe Disposable Ball Tip Probe 2.3mm ball; 130mm x 2.2mm electrode FDA UDI
- Model / Reference
- BTP2.3-130/10 EUDAMEDFDA UDIBTP3.0-100/10 EUDAMEDFDA UDI
- Description
- Disposable Stimulation Probe Disposable Ball Tip Probe 3mm ball; 100mm x 2.2mm electrode FDA UDIDisposable Stimulation Probe Disposable Ball Tip Probe 2.3mm ball; 130mm x 2.2mm electrode FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718375863916 EUDAMEDFDA UDI08718375863718 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08718375863916 EUDAMEDB-08718375863718 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
Disposable Stimulation Probe - Disposable Ball Tip Probe by Technomed Europe — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-08718375863916 | 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 (4)
- EUDAMED d7b288cd-0b9f-4a82-8074-b7be57845d2c 61 fields · synced Aug 3, 2026
- FDA UDI 0dd67d1d-e561-4c33-98d2-de716400b51c 34 fields · synced May 30, 2026
- FDA UDI 5fa600f0-05df-42b7-9005-8dc34878b691 34 fields · synced May 30, 2026
- EUDAMED 9af580f9-ec06-4308-87f4-3f43d2a873ac 61 fields · synced Aug 3, 2026