Identity
- Trade Name
- Serial 8P Straight Cable EUDAMED
- Device Name
- Accessories for Electrocardiograph EUDAMED
- Model / Reference
- CJS-04DA5 EUDAMEDCJS-04DA1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04538612048715 EUDAMED04538612048708 EUDAMED
- Basic UDI-DI
- 4538612010019G EUDAMED
- EMDN Code
- Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS 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
Serial 8P Straight Cable 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 | 4538612010019G | 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 b5777120-d35c-42b8-a25c-8268603d64c2 61 fields · synced Jul 30, 2026
- EUDAMED 6367b950-c86b-4e19-98b8-b67fff23c68f 61 fields · synced May 19, 2026