Identity
- Trade Name
- Disposable ECG Lead Wire EUDAMEDUnimed FDA UDI
- Generic Name
- Electrocardiographic lead set, single-use FDA UDI
- Device Name
- Disposable ECG Lead Wires EUDAMEDDisposable ECG Lead Wire Nihon Kohden FDA UDI
- Model / Reference
- NKB3-90DS-I EUDAMEDFDA UDI
- Description
- Disposable ECG Lead Wire Nihon Kohden FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936735493043 EUDAMEDFDA UDI
- Basic UDI-DI
- 69456648DEC1VD EUDAMED
- FDA Product Code
- DSA FDA UDI
- EMDN Code
- Z12050385 ELECTROCARDIOGRAPHS - CONSUMABLES EUDAMED
- GMDN Term
- Electrocardiographic lead set, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2900 FDA UDI
- Market of Registration
- Czechia 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
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrocardiographic lead set, single-use
Unimed by Unimed Medical Supplies, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic lead set, single-use.
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- Med-Dyne — MED-DYNE · 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
- Unimed Medical Supplies, Inc.
Sources (2)
- FDA UDI 446f47d0-4179-4bc6-a946-7b43e11c404c 33 fields · synced Jul 12, 2026
- EUDAMED 2ec2bad1-fed3-4b00-b08e-c2f41b2f6012 61 fields · synced Jul 12, 2026