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Patient Cable CP-105T/U
EUDAMEDClass I (EU MDR)
Ref CPV-02BKPU-2036Ref CPR-02BKPDU2033
Identity
- Trade Name
- Patient Cable CP-105T/U EUDAMED
- Device Name
- Electrocardiographic lead set, reusable EUDAMED
- Model / Reference
- CPV-02BKPU-2036 EUDAMEDCPR-02BKPDU2033 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04538612910616 EUDAMED04538612910630 EUDAMED
- Basic UDI-DI
- 4538612030009U EUDAMED
- EMDN Code
- C020599 CARDIAC DIAGNOSTIC DEVICES - OTHER 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
Patient Cable CP-105T/U by Fukuda Denshi 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 | 4538612030009U | Class I | Active |
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Manufacturer
- Manufacturer
- Fukuda Denshi Co., Ltd.
- EUDAMED SRN
- JP-MF-000008253
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 9ac54fad-0dd8-41d7-b1f4-58be9aa1ef3e 61 fields · synced Jul 22, 2026
- EUDAMED 09682c86-c273-48d2-b01e-5ec2c607234a 61 fields · synced May 19, 2026