Identity
- Trade Name
- Daiwha Corp., Ltd. EUDAMED
- Device Name
- DU-515 EUDAMED
- Model / Reference
- DU-515 EUDAMEDDW-MTS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800009401745 EUDAMED
- Basic UDI-DI
- B-08800009401745 EUDAMED
- EMDN Code
- K0202010201 ULTRASONIC OPEN SURGERY HANDPIECES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Daiwha Corp., Ltd. by Daiwha Corp., Ltd. — Class IIb — 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-08800009401745 | 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 f63ae1b2-1efa-4f5b-8ff7-e65b8e5b776b 61 fields · synced Jun 19, 2026