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NeoLead® Radiolucent CE
EUDAMEDFDA UDIClass I (EU MDR)
Ref N305CEModel NeoLead®
Identity
- Trade Name
- NeoLead® Radiolucent CE 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® EUDAMEDN305CE EUDAMEDRadioLucent CE 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
- N305CE FDA UDI
- Primary DI / UDI-DI
- 10812594011808 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
NeoLead® Radiolucent CE by Neotech Products LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 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 4f9a6864-c664-463d-a3b2-ffe9984e396b 61 fields · synced Jul 22, 2026
- FDA UDI caf8948f-79c0-414e-bb74-6c815cdf5cf5 34 fields · synced May 30, 2026