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Reusable Handheld Bipolar Felt Pad Stimulating Electrode
EUDAMEDFDA UDIClass I (EU MDR)
Ref 9013L0362
Identity
- Trade Name
- Reusable Handheld Bipolar Felt Pad Stimulating Electrode EUDAMEDNatus FDA UDI
- Generic Name
- Analytical scalp electrode, reusable FDA UDI
- Device Name
- EMG Electrodes and Accessory Products EUDAMEDReusable Handheld Bipolar Felt Pad Stimulating Electrode FDA UDI
- Model / Reference
- 9013L0362 EUDAMEDFDA UDI
- Description
- Reusable Handheld Bipolar Felt Pad Stimulating Electrode FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830048323 EUDAMEDFDA UDI
- Basic UDI-DI
- 0382830059145U4 EUDAMED
- 510(k) Number
- K934580 FDA UDI
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- N010101 ELECTROMYOGRAPHIC ELECTRODES EUDAMED
- GMDN Term
- Analytical scalp electrode, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Reusable Handheld Bipolar Felt Pad Stimulating Electrode by Natus Manufacturing Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0382830059145U4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Natus Manufacturing Limited
- EUDAMED SRN
- IE-MF-000000799
Sources (2)
- EUDAMED 897ce79c-afa6-4900-af30-bd5c0e337380 61 fields · synced Jul 9, 2026
- FDA UDI 0a2e2e76-279e-4c6c-815e-1b66a20fd0c3 34 fields · synced May 30, 2026