Identity
- Trade Name
- Patient Cable CME-77 EUDAMED
- Device Name
- Accessories for Electrocardiograph EUDAMED
- Model / Reference
- CME-77FJKU EUDAMEDCME-77FJKU-W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04538612915376 EUDAMED04538612915383 EUDAMED
- Basic UDI-DI
- 4538612010019G EUDAMED
- EMDN Code
- Z12050380 ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Category: Electrocardiographic lead set, reusable
Patient Cable CME-77 by Fukuda Denshi Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Electrocardiographic lead set, reusable.
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- Unimed — Unimed Medical Supplies, Inc. · Class II
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 bc4bb155-87d4-419d-b2fb-782c297a5969 61 fields · synced Jul 17, 2026
- EUDAMED 9f4b69c7-a4a0-4af7-858b-bac10fcefcdd 61 fields · synced May 19, 2026