Identity
- Trade Name
- Daiwha Corp., Ltd. EUDAMED
- Device Name
- DE-400E EUDAMED
- Model / Reference
- DE-400E EUDAMEDDW-MTS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800009400489 EUDAMED
- Basic UDI-DI
- B-08800009400489 EUDAMED
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Category: Foot-switch, electrical
Daiwha Corp., Ltd. by Daiwha Corp., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08800009400489 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Daiwha Corp., Ltd.
- EUDAMED SRN
- KR-MF-000024402
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED a41af878-6549-4333-8fbc-d898e0633790 61 fields · synced Jun 19, 2026