← Back to catalogue
Disposable Monopolar Probe
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref NP003Ref 302898-000
Identity
- Trade Name
- Disposable Monopolar Probe EUDAMEDNeural Pathways, LLC FDA UDICadwell FDA UDI
- Generic Name
- Subdermal needle electrode FDA UDINerve-locating system probe, single-use FDA UDI
- Device Name
- Disposable Stimulation Probes and Surgical Instruments EUDAMEDDisposable Monopolar Probe 1pc FDA UDIDisposable Monopolar Probe; 100 x 1.2mm electrode FDA UDI
- Model / Reference
- NP003 EUDAMEDFDA UDI302898-000 EUDAMEDFDA UDI
- Description
- Disposable Monopolar Probe 1pc FDA UDIDisposable Monopolar Probe; 100 x 1.2mm electrode FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718375863503 EUDAMEDFDA UDI08720791374938 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08718375863503 EUDAMEDB-08720791374938 EUDAMED
- FDA Product Code
- GXZ FDA UDIIKT FDA UDI
- EMDN Code
- Z12101185 PERIPHERAL OR CENTRAL NEURO STIMULATION AND ASSESSMENT INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Subdermal needle electrode FDA UDINerve-locating system probe, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1350 FDA UDI890.1385 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
No
FDA UDIFDA UDI
MR Unsafe FDA UDI
Disposable Monopolar 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-08718375863503 | 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 (4)
- EUDAMED 050490fa-5e31-4952-b7bb-ab483f4a4ed7 61 fields · synced Jul 24, 2026
- FDA UDI 40a421e9-5916-4aba-b0e6-7215da473015 35 fields · synced May 29, 2026
- FDA UDI 2d1c7447-2baa-4817-a3a1-e13db98ce67e 34 fields · synced May 30, 2026
- EUDAMED 0718868e-f4bd-4d32-ae72-90128942229c 61 fields · synced Jul 24, 2026