Identity
- Trade Name
- ES-5400 EUDAMED
- Device Name
- ES-5400 EUDAMED
- Model / Reference
- ES-5400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04983087011397 EUDAMED
- Basic UDI-DI
- B-04983087011397 EUDAMED
- EMDN Code
- Z120601 ELECTROTHERAPY EQUIPMENT (INCLUDED TENS) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Es-5400 by Ito Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04983087011397 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ito Co., Ltd.
- EUDAMED SRN
- JP-MF-000021681
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED b46949c7-2155-4d00-aeb1-d15949814275 61 fields · synced Jul 30, 2026