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ECG Patient Cable
EUDAMEDClass I (EU MDR)
Ref PL-U3A, PL-U3B, PL-B3A, PL-B3B, PL-M3A, PL-M3BModel PL-U3A, PL-U3B, PL-U3C, PL-U3D, PL-B3A, PL-B3B, PL-B3C, PL-B3D, PL-M3A, PL-M3B, PL-M3C, PL-M3D
Identity
- Trade Name
- ECG Patient Cable EUDAMED
- Device Name
- ECG Patient Cable EUDAMED
- Model / Reference
- PL-U3A, PL-U3B, PL-U3C, PL-U3D, PL-B3A, PL-B3B, PL-B3C, PL-B3D, PL-M3A, PL-M3B, PL-M3C, PL-M3D EUDAMEDPL-U3A, PL-U3B, PL-B3A, PL-B3B, PL-M3A, PL-M3B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970912081036 EUDAMED
- Basic UDI-DI
- 697091208PL22 EUDAMED
- EMDN Code
- Z12050485 HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
ECG Patient Cable by Biomedical Instruments Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697091208PL22 | Class I | Active |
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Manufacturer
- Manufacturer
- Biomedical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000016483
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED b6cfde56-21df-4f35-b1ee-9ee521c934d9 61 fields · synced Jun 18, 2026
- EUDAMED b6cfde56-21df-4f35-b1ee-9ee521c934d9-1 61 fields · synced Jun 10, 2026