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Vital Signs™ Diagnostic Cardiology Leadwire, Dedicated Banana IEC, 66 cm/26 in,…
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2020559-016
Identity
- Trade Name
- Vital Signs™ Diagnostic Cardiology Leadwire, Dedicated Banana IEC, 66 cm/26 in, C4R EUDAMEDVital Signs™ FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- Vital Signs™ Individual replacement leadwires for banana-ended leadwires EUDAMEDVital Signs™ Diagnostic Cardiology Leadwire, Dedicated Banana, IEC, 66 cm/26 in, C4R FDA UDI
- Model / Reference
- 2020559-016 EUDAMEDFDA UDI
- Description
- Vital Signs™ Diagnostic Cardiology Leadwire, Dedicated Banana, IEC, 66 cm/26 in, C4R FDA UDI
Identifiers
- Catalog Number
- 2020559-016 FDA UDI
- Primary DI / UDI-DI
- 10190752183513 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190752TDHEL1412UW EUDAMED
- Direct Marketing DI
- 10190752183513 EUDAMED
- FDA Product Code
- DSA 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
- 870.2900 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Vital Signs™ Diagnostic Cardiology Leadwire, Dedicated Banana IEC, 66 cm/26 in,… by AirLife Finland Oy — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 0190752TDHEL1412UW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- AirLife Finland Oy
- EUDAMED SRN
- FI-MF-000001482
Sources (2)
- EUDAMED ee09788c-8e45-43ce-9275-a15ae29f0155 61 fields · synced Oct 6, 2026
- FDA UDI f3710d02-47c2-4bcc-859c-7b83d464dec2 36 fields · synced May 30, 2026