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Disposable Monopolar Needle Electrode, pre-wired, trocar tip
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref TE/AP2545-335/01
Identity
- Trade Name
- Disposable Monopolar Needle Electrode, pre-wired, trocar tip EUDAMEDTechnomed Europe FDA UDI
- Generic Name
- Electromyographic needle electrode, single-use FDA UDI
- Device Name
- Disposable Monopolar Needle Electrodes EUDAMEDDisposable Monopolar Needle Electrode, pre-wired, trocar tip, 0.75m leadwire, yellow FDA UDI
- Model / Reference
- TE/AP2545-335/01 EUDAMEDFDA UDI
- Description
- Disposable Monopolar Needle Electrode, pre-wired, trocar tip, 0.75m leadwire, yellow FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718375861998 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08718375861998 EUDAMED
- FDA Product Code
- IKT FDA UDIGXZ FDA UDI
- EMDN Code
- N010101 ELECTROMYOGRAPHIC ELECTRODES EUDAMED
- GMDN Term
- Electromyographic needle electrode, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1385 FDA UDI882.1350 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
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 26 Gauge FDA UDIOuter Diameter — 0.45 Millimeter FDA UDILength — 25 Millimeter FDA UDI
Disposable Monopolar Needle Electrode, pre-wired, trocar tip 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-08718375861998 | 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 2a5093d0-a1f8-46c3-a002-a9342c902cc1 61 fields · synced Jun 20, 2026
- FDA UDI 252d5fa1-b912-4637-a1b1-05a4a2645117 35 fields · synced May 30, 2026