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Natus Reusable Snap Leads and Natus Disposable Snap Electrodes
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1410500
Identity
- Trade Name
- Natus Reusable Snap Leads and Natus Disposable Snap Electrodes EUDAMEDNatus FDA UDI
- Generic Name
- Analytical non-scalp cutaneous electrode FDA UDI
- Device Name
- Disposable Circular Center Snap Adhesive Electrode EUDAMEDFDA UDI
- Model / Reference
- 1410500 EUDAMEDFDA UDI
- Description
- Disposable Circular Center Snap Adhesive Electrode FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830025263 EUDAMEDFDA UDI
- Basic UDI-DI
- 00382830059022D5 EUDAMED
- Direct Marketing DI
- 00382830025263 EUDAMED
- 510(k) Number
- K172703 FDA UDI
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- V9015 ELECTRODES AND PROBES CUTANEOUS CONDUCTIVE SUBSTANCES EUDAMED
- GMDN Term
- Analytical non-scalp cutaneous electrode 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
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
Natus Reusable Snap Leads and Natus Disposable Snap Electrodes by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — Class I — MDR, FDA UDI — listed in…
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 | 00382830059022D5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- EUDAMED SRN
- CA-MF-000004001
- Authorised Representative
- Natus Manufacturing Ltd IE-AR-000000884
Sources (2)
- EUDAMED d5fbb3eb-14ba-4bb7-90b1-218387a5300f 61 fields · synced Oct 6, 2026
- FDA UDI 0b8a4910-51b1-49df-8795-d4d085225e2e 34 fields · synced May 30, 2026