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Disposable Monopolar Needle Electrode, pre-wired, pencil tip
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref TE/AP7545-335
Identity
- Trade Name
- Disposable Monopolar Needle Electrode, pre-wired, pencil 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, pencil tip, 0.75m leadwire, violet FDA UDI
- Model / Reference
- TE/AP7545-335 EUDAMEDFDA UDI
- Description
- Disposable Monopolar Needle Electrode, pre-wired, pencil tip, 0.75m leadwire, violet FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718375861899 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08718375861899 EUDAMED
- FDA Product Code
- GXZ FDA UDIIKT 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
- 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 UDI
Dimensions & Sizes
- Size
- Length — 75 Millimeter FDA UDIOuter Diameter — 0.45 Millimeter FDA UDINeedle Gauge — 26 Gauge FDA UDI
Disposable Monopolar Needle Electrode, pre-wired, pencil 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-08718375861899 | 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 fc10cf37-8c70-4628-959a-5c68d5b443b2 61 fields · synced Jul 24, 2026
- FDA UDI 895be22b-4b6e-40cc-9887-29c6cd00389f 35 fields · synced May 30, 2026