Identity
- Device Name
- Accufuser EUDAMED
- Model / Reference
- C0015L EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-C0015LUB EUDAMED
- Basic UDI-DI
- B-C0015LUB EUDAMED
- EMDN Code
- A05010101 ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Accufuser by Woo Young Medical Co., 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-C0015LUB | Class IIb | Active |
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Manufacturer
- Manufacturer
- Woo Young Medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000022134
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 6e0f1ecd-7db0-49d0-bb91-621a49d27778 61 fields · synced Jun 18, 2026