← Back to catalogue
ECG Patient Cable
EUDAMEDClass I (EU MDR)
Ref 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-M3DRef PL-B3BRef PL-B3DRef PL-B3ARef PL-B3CRef PL-U3CRef PL-M3ARef 05E14Model PL-U3A,PL-U3B,PL-U3C,PL-U3D,PL-B3A,PL-B3B,PL-B3C,PL-B3D,PL-M3A,PL-M3B, PL-M3C, PL-M3D,10A16,10E16,10A17,10A21,10E21,07A13,07E13,07A14,07E14,07A21,05S13,05E14,05S14,05A20,05E20,05S22,05S24,04S10,04S11,04S21,04S22,03S21,10E44,10E45,10E46,10E47,10E48,10E49Ref 07E14
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-M3B EUDAMEDPL-B3B EUDAMEDPL-B3D EUDAMEDPL-B3A EUDAMEDPL-B3C EUDAMEDPL-U3C EUDAMEDPL-M3A EUDAMEDPL-U3A,PL-U3B,PL-U3C,PL-U3D,PL-B3A,PL-B3B,PL-B3C,PL-B3D,PL-M3A,PL-M3B, PL-M3C, PL-M3D,10A16,10E16,10A17,10A21,10E21,07A13,07E13,07A14,07E14,07A21,05S13,05E14,05S14,05A20,05E20,05S22,05S24,04S10,04S11,04S21,04S22,03S21,10E44,10E45,10E46,10E47,10E48,10E49 EUDAMED05E14 EUDAMED07E14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970912081081 EUDAMED06970912081067 EUDAMED06970912081395 EUDAMED06970912081050 EUDAMED06970912081388 EUDAMED06970912081364 EUDAMED06970912081074 EUDAMED06970912083139 EUDAMED06970912083061 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
- Austria EUDAMEDGermany EUDAMEDItaly 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomedical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000016483
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (9)
- EUDAMED c11ee294-59a4-4d76-b5ac-758de0e04797 61 fields · synced Oct 6, 2026
- EUDAMED 50da6476-d4ef-48fa-8540-f1c1a8ba2741 61 fields · synced May 17, 2026
- EUDAMED d92e4f1f-9937-44f5-8d69-4a357c2f5b27 61 fields · synced May 17, 2026
- EUDAMED 06ce9841-ac5a-44c2-94cb-4b8d796afe88 61 fields · synced May 18, 2026
- EUDAMED 656c64e5-c4db-4326-9bcd-ae47effecf38 61 fields · synced May 18, 2026
- EUDAMED 43f14a43-c5db-4709-9b59-1f55852abdd3 61 fields · synced May 18, 2026
- EUDAMED 7ba04db8-3573-465c-bc64-216cb4e719d0 61 fields · synced May 18, 2026
- EUDAMED b5984463-afbd-4408-ab80-b573f68964be 61 fields · synced Jul 8, 2026
- EUDAMED 8e474655-edf3-4b59-978d-7f72a4bbdeff 61 fields · synced Jul 8, 2026