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6U Universal ECG Electrode Belt with Handles
EUDAMEDClass I (EU MDR)
Ref 11001-LM
by Levmed Ltd.
Identity
- Trade Name
- 6U Universal ECG Electrode Belt with Handles EUDAMED
- Device Name
- 6U Universal ECG Electrode Belt with Handles EUDAMED
- Model / Reference
- 11001-LM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290016423013 EUDAMED
- Basic UDI-DI
- 7290016423ECGB6Uh5F EUDAMED
- Direct Marketing DI
- 07290016423013 EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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 electrode, single-use
6U Universal ECG Electrode Belt with Handles by Levmed Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 7290016423ECGB6Uh5F | Class I | Active |
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Manufacturer
- Manufacturer
- Levmed Ltd.
- EUDAMED SRN
- IL-MF-000008545
- Authorised Representative
- Kinesis Medical B.V. NL-AR-000000432
Sources (1)
- EUDAMED 86d1cdb7-c21c-4130-a980-ccc62a4ea357 61 fields · synced Jul 20, 2026