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Holder for Dantec DCN Disposable Concentric Needle Electrode
EUDAMEDFDA UDIClass I (EU MDR)
Ref 9013C0014
Identity
- Trade Name
- Holder for Dantec DCN Disposable Concentric Needle Electrode EUDAMEDNatus FDA UDI
- Generic Name
- Analytical non-scalp cutaneous lead FDA UDI
- Device Name
- Holder for Dantec DCN Disposable Concentric Needle Electrode EUDAMEDHolder Dantec DCN 1.5M FDA UDI
- Model / Reference
- 9013C0014 EUDAMEDFDA UDI
- Description
- Holder Dantec DCN 1.5M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830047371 EUDAMEDFDA UDI
- Basic UDI-DI
- 038283NA00012DS EUDAMED
- FDA Product Code
- IKD FDA UDI
- EMDN Code
- N010101 ELECTROMYOGRAPHIC ELECTRODES EUDAMED
- GMDN Term
- Analytical non-scalp cutaneous lead FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1175 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Holder for Dantec DCN Disposable Concentric Needle 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 | 038283NA00012DS | 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 88a80418-a1ae-4c40-b464-693479c4ccaf 61 fields · synced Jun 18, 2026
- FDA UDI 5125f1ca-9f88-40d9-b434-2d3007f14e3c 33 fields · synced May 29, 2026