LevMed Dedicated ECG Electrode Belt with Straps. D-Type with Screws Connector (…
EUDAMEDFDA UDIClass I (EU MDR)
by Levmed Ltd.
Identity
- Trade Name
- LevMed Dedicated ECG Electrode Belt with Straps. D-Type with Screws Connector (ARs-DT-WS-LM EUDAMEDLevmed ECG 12 Lead Electrodes belt FDA UDI
- Generic Name
- Electrocardiographic electrode, reusable FDA UDI
- Device Name
- Dedicated ECG Electrode Belt with Straps EUDAMEDDedicated ECG Electrode Belt with Straps. D-Type With Screws Connector FDA UDI
- Model / Reference
- 11060/s-LM EUDAMED11061/s-LM EUDAMEDARs FDA UDI
- Description
- Dedicated ECG Electrode Belt with Straps. D-Type With Screws Connector FDA UDI
Identifiers
- Catalog Number
- A-11061/s-AL FDA UDI
- Primary DI / UDI-DI
- 07290016423068 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290016423ECGBDDs6K EUDAMED
- Direct Marketing DI
- 07290016423068 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
- Slovakia 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
LevMed Dedicated ECG Electrode Belt with Straps. D-Type with Screws Connector (… by Levmed Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Electrocardiographic electrode, single-use.
- ECG leadwire — Shenzhen City Teveik Technology Co., Ltd. · Class I
- Elektrody EKG — SORIMEX sp. z o.o. · Class I
- ECG — Zoll Medical Corporation · Class II
- SWAROMED — TYROLMED GmbH · Class II
- SWAROMED — TYROLMED GmbH · Class II
- SWAROMED — TYROLMED GmbH · Class II
- PG10S /RU26 — FIAB S.p.A. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7290016423ECGBDDs6K | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Levmed Ltd.
- EUDAMED SRN
- IL-MF-000008545
- Authorised Representative
- Kinesis Medical B.V. NL-AR-000000432
Sources (2)
- EUDAMED 69745a35-2ee2-4812-bc24-8dc96afe9a20 61 fields · synced Jul 9, 2026
- FDA UDI 750e4490-5e57-4b91-8f0b-568c3e8294e2 35 fields · synced May 27, 2026