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Reusable Snap Lead Cable 2.0m (78"), (1.5mm DIN) Orange, 2/pkg
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1411524
Identity
- Trade Name
- Reusable Snap Lead Cable 2.0m (78"), (1.5mm DIN) Orange, 2/pkg EUDAMEDXltek FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- Natus Reusable Snap Leads and Natus Disposable Snap Electrodes EUDAMEDEKG Snap On Cables 78in/200cm FDA UDI
- Model / Reference
- 1411524 EUDAMEDFDA UDI
- Description
- EKG Snap On Cables 78in/200cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830025362 EUDAMEDFDA UDI
- Basic UDI-DI
- 00382830059015D8 EUDAMED
- Direct Marketing DI
- 00382830025362 EUDAMED
- 510(k) Number
- K024322 FDA UDI
- FDA Product Code
- MNR FDA UDI
- EMDN Code
- Z12100380 ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Reusable Snap Lead Cable 2.0m (78"), (1.5mm DIN) Orange, 2/pkg 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 | 00382830059015D8 | 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 77b39eaf-b436-4590-a838-2ffd7d4c0941 61 fields · synced Jun 18, 2026
- FDA UDI 313f9108-2ed2-480d-8e3d-c11ef7fa0da8 34 fields · synced May 30, 2026