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Disposable Stimulation Probe - Disposable Ball Tip Probe
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BTP3.0-200/1
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; 200mm x 1.6mm electrode FDA UDI
- Model / Reference
- BTP3.0-200/1 EUDAMEDFDA UDI
- Description
- Disposable Stimulation Probe Disposable Ball Tip Probe 3mm ball; 200mm x 1.6mm electrode FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718375863855 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08718375863855 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-08718375863855 | 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 28f93260-5b7e-4025-a886-f22e9760243e 61 fields · synced Jul 14, 2026
- FDA UDI e0c29948-c2db-4876-8d8b-d34d57a09b8c 34 fields · synced May 30, 2026