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Norav Medical
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref C3-C-LL-ODU-VModel Accessories
Identity
- Trade Name
- C3-C-LL-ODU-V EUDAMEDNorav Medical FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- C3-C-E-ODU EUDAMEDECG Input Cable with dedicated ODU Plug to 3 Leads with Clip connectors (Ventri) FDA UDI
- Model / Reference
- C3-C-LL-ODU-V EUDAMEDFDA UDIAccessories EUDAMED
- Description
- ECG Input Cable with dedicated ODU Plug to 3 Leads with Clip connectors (Ventri) FDA UDI
Identifiers
- Catalog Number
- C3-C-LL-ODU-V FDA UDI
- Primary DI / UDI-DI
- 04260498566105 EUDAMEDFDA UDI
- Basic UDI-DI
- 426049856DE55252NMCBLTD 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
Norav Medical by Norav Medical Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic lead set, reusable.
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- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- ECG D-SUB2 C 3.5/3.1 x14 AHA — Schiller AG · Class I
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Norav Medical Inc.
Sources (2)
- FDA UDI d51a61c5-614a-49f4-a88f-ca7f0a5bb6f0 35 fields · synced Jul 11, 2026
- EUDAMED 3a93cd6b-9d91-4afe-9f19-76e984e9ad8f 61 fields · synced Jul 11, 2026