Identity
- Trade Name
- Daiwha Corp., Ltd. EUDAMED
- Device Name
- PRC-01 EUDAMED
- Model / Reference
- RPC-01 EUDAMEDDW-MTS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800009400939 EUDAMED
- Basic UDI-DI
- B-08800009400939 EUDAMED
- EMDN Code
- L0399 GENERAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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 I — 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-08800009400939 | Class I | 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 b431988c-e220-4bb9-98e6-cfc9688aee9c 61 fields · synced Jun 19, 2026