Identity
- Trade Name
- Earth wire EUDAMED
- Device Name
- Accessories for Measuring and Monitoring Device for Vital Signs EUDAMED
- Model / Reference
- CE-01A EUDAMEDCE-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04538612012907 EUDAMED04538612012914 EUDAMED
- Basic UDI-DI
- 4538612020019P EUDAMED
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS 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
Earth wire 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 | 4538612020019P | 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 6da33736-3d3e-40e1-864d-c219c07c3213 61 fields · synced Jul 19, 2026
- EUDAMED dc934eec-4bc9-4bd9-90be-00b41726b1db 61 fields · synced May 17, 2026