Identity
- Device Name
- Accufuser Omnibus EUDAMED
- Model / Reference
- SM050715XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-SM050715XLM3 EUDAMED
- Basic UDI-DI
- B-SM050715XLM3 EUDAMED
- EMDN Code
- A05010202 ELASTOMERIC SYSTEMS - VARIABLE FLOW WITH 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 Omnibus 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-SM050715XLM3 | 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 bfb528ff-63b2-4451-801a-4365f1b3ebf3 61 fields · synced Oct 6, 2026