Identity
- Trade Name
- C3-C-E-ODU EUDAMEDNorav ECG Input Cable FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- C3-C-E-ODU EUDAMEDECG Input Cable with dedicated ODU Plug with IEC color coding to 3 Leads with Clip connectors FDA UDI
- Model / Reference
- Accessories EUDAMEDC3-C-E-ODU EUDAMEDFDA UDI
- Description
- ECG Input Cable with dedicated ODU Plug with IEC color coding to 3 Leads with Clip connectors FDA UDI
Identifiers
- Catalog Number
- C3-C-E-ODU FDA UDI
- Primary DI / UDI-DI
- 04260498564293 EUDAMEDFDA UDI
- Basic UDI-DI
- 426049856DE55252NMCBLTD EUDAMED
- Direct Marketing DI
- 04260498564293 EUDAMED
- FDA Product Code
- IKD FDA UDI
- EMDN Code
- Z12050380 ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1175 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Category: Electrocardiographic lead set, reusable
C3-C-E-Odu by Norav Medical GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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- Unimed — Unimed Medical Supplies, Inc. · Class II
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 | 426049856DE55252NMCBLTD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Norav Medical GmbH
- EUDAMED SRN
- DE-MF-000006715
Sources (2)
- EUDAMED e6449103-867d-431c-b527-40a2780fc6c6 61 fields · synced Oct 6, 2026
- FDA UDI 5dcba29a-7d84-4e5b-8eaa-c5b3eccc35bd 35 fields · synced May 30, 2026