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IEC 2-electrode 1-CH patient cable 125 mm
EUDAMEDClass I (EU MDR)
Ref S0000022709Model ECG Patient Cable
Identity
- Trade Name
- IEC 2-electrode 1-CH patient cable 125 mm EUDAMED
- Device Name
- Patient Cables EUDAMED
- Model / Reference
- ECG Patient Cable EUDAMEDS0000022709 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430035221035 EUDAMED
- Basic UDI-DI
- 643003522PatientCableF5 EUDAMED
- EMDN Code
- Z12050480 HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Electrocardiographic lead set, reusable
IEC 2-electrode 1-CH patient cable 125 mm by Bittium Biosignals Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Electrocardiographic lead set, reusable.
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- 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 (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 643003522PatientCableF5 | Class I | Active |
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Manufacturer
- Manufacturer
- Bittium Biosignals Oy
- EUDAMED SRN
- FI-MF-000013983
Sources (1)
- EUDAMED f4d2397a-1eaf-40d2-9458-3bbc10c4516c 61 fields · synced Jul 22, 2026