Identity
- Trade Name
- Patient Cable CP-105T/U EUDAMED
- Device Name
- Electrocardiographic lead set, reusable EUDAMED
- Model / Reference
- CP-202T-2037 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04538612910593 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fukuda Denshi Co., Ltd.
- EUDAMED SRN
- JP-MF-000008253
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED f6982e49-df8c-46fd-aab2-92b378f1e3e0 61 fields · synced Jun 18, 2026