6U Universal ECG Electrode Belt with Straps
EUDAMEDFDA UDIClass I (EU MDR)
by Levmed Ltd.
Identity
- Trade Name
- 6U Universal ECG Electrode Belt with Straps EUDAMEDLevmed ECG 12 Lead Electrodes belt FDA UDI
- Generic Name
- Electrocardiographic electrode, reusable FDA UDI
- Device Name
- 6U Universal ECG Electrode Belt with Straps EUDAMEDUniversal ECG Electrodes Belt with Straps FDA UDI
- Model / Reference
- 11002n-LM EUDAMED6Us FDA UDI
- Description
- Universal ECG Electrodes Belt with Straps FDA UDI
Identifiers
- Catalog Number
- A-11002n-LM FDA UDI
- Primary DI / UDI-DI
- 07290016423020 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290016423ECGB6Us65 EUDAMED
- FDA Product Code
- DRX FDA UDI
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
- GMDN Term
- Electrocardiographic electrode, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2360 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Electrocardiographic electrode, single-use
6U Universal ECG Electrode Belt with Straps by Levmed Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7290016423ECGB6Us65 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Levmed Ltd.
- EUDAMED SRN
- IL-MF-000008545
- Authorised Representative
- Kinesis Medical B.V. NL-AR-000000432
Sources (2)
- EUDAMED 55d5786c-6517-4a06-80d4-2e2bfbe896ae 61 fields · synced Jul 20, 2026
- FDA UDI 82c41ab0-aad9-498f-9c71-3f8478f7d3d7 35 fields · synced May 29, 2026