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Disposable Needle Electrode for EMG
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 320025
Identity
- Trade Name
- Disposable Needle Electrode for EMG EUDAMED
- Device Name
- Disposable Concentric Needle Electrodes EUDAMED
- Model / Reference
- 320025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08718375863077 EUDAMED
- Basic UDI-DI
- B-08718375863077 EUDAMED
- EMDN Code
- N010101 ELECTROMYOGRAPHIC ELECTRODES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Disposable Needle Electrode for EMG by Technomed Europe — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K990015 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08718375863077 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Technomed Europe
- EUDAMED SRN
- NL-MF-000000064
Sources (2)
- EUDAMED 266e2790-d64c-4d16-9b45-9be711f0b07c 61 fields · synced Jun 19, 2026
- FDA 510(k) K990015 1 fields · synced May 18, 2026