NeoLead® ECG Electrodes Standard
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- NeoLead® ECG Electrodes Standard EUDAMEDNeoLead® FDA UDI
- Generic Name
- Neonatal electrocardiographic electrode FDA UDI
- Device Name
- NeoLead® EUDAMEDNeoLead is a set of three/five ECG electrodes used on term neonates, infants, and pediatric patients. An electrocardiograph electrode (per FDA regulation# 870.2360 ) is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. FDA UDI
- Model / Reference
- NeoLead® EUDAMEDN301 EUDAMEDStandard FDA UDI
- Description
- NeoLead is a set of three/five ECG electrodes used on term neonates, infants, and pediatric patients. An electrocardiograph electrode (per FDA regulation# 870.2360 ) is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. FDA UDI
Identifiers
- Catalog Number
- N301 FDA UDI
- Primary DI / UDI-DI
- 10812594011051 EUDAMEDFDA UDI
- Basic UDI-DI
- 081259401N30000KB EUDAMED
- FDA Product Code
- DRX FDA UDI
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
- GMDN Term
- Neonatal electrocardiographic electrode FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2360 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Electrocardiographic electrode, single-use
NeoLead® ECG Electrodes Standard by Neotech Products LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081259401N30000KB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Neotech Products LLC
- EUDAMED SRN
- US-MF-000001895
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED d0dea6a1-3fc5-49dc-983e-42d943f51cb8 61 fields · synced Jun 18, 2026
- FDA UDI e238d795-f40c-4277-8d0d-0f2b5163251f 34 fields · synced May 30, 2026