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Disposable ECG Electrodes
EUDAMEDClass I (EU MDR)
Ref 301A, 301B, 301C, 301D, 301E, 301F, 301G, 301H, 301I, 301J, 301K, 301L, 301M, 301N, 301O, 301P
Identity
- Trade Name
- Disposable ECG Electrodes EUDAMED
- Device Name
- Disposable ECG Electrodes EUDAMED
- Model / Reference
- 301A, 301B, 301C, 301D, 301E, 301F, 301G, 301H, 301I, 301J, 301K, 301L, 301M, 301N, 301O, 301P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939411511048 EUDAMED
- Basic UDI-DI
- 69394115301V7 EUDAMED
- Unit of Use DI
- 06939411511062 EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Disposable ECG Electrodes by Baisheng Medical Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic electrode, single-use.
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- SWAROMED — TYROLMED GmbH · Class II
- PG10S /RU26 — FIAB S.p.A. · Class I
- Medline — MEDLINE INDUSTRIES, 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 | 69394115301V7 | Class I | Active |
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Manufacturer
- Manufacturer
- Baisheng Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000024558
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED 6b4ca4e0-ccfb-4f0a-9e46-2ead8ef77331 61 fields · synced Jul 16, 2026
- EUDAMED 6b4ca4e0-ccfb-4f0a-9e46-2ead8ef77331-1 61 fields · synced Jun 10, 2026