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Accufuser M4C
EUDAMEDClass IIb (EU MDR)
Ref MC23LRef MC12L-NModel MC12LRef MC24M-NModel MC24MRef MC12SRef MC24SRef MC23MRef MC12MRef MC57L-NModel MC57LRef MC35LRef MC12M-NRef MC25LRef MC48L
Identity
- Device Name
- Accufuser M4C EUDAMED
- Model / Reference
- MC23L EUDAMEDMC12L EUDAMEDMC12L-N EUDAMEDMC24M EUDAMEDMC24M-N EUDAMEDMC12S EUDAMEDMC24S EUDAMEDMC23M EUDAMEDMC12M EUDAMEDMC57L EUDAMEDMC57L-N EUDAMEDMC35L EUDAMEDMC12M-N EUDAMEDMC25L EUDAMEDMC48L EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-MC23LV9 EUDAMEDD-MC12LN98 EUDAMEDD-MC24MN9U EUDAMEDD-MC12SVF EUDAMEDD-MC24SVS EUDAMEDD-MC23MVB EUDAMEDD-MC12MV3 EUDAMEDD-MC57LNAV EUDAMEDD-MC35LVL EUDAMEDD-MC57LW4 EUDAMEDD-MC24MVE EUDAMEDD-MC12MN9B EUDAMEDD-MC25LVF EUDAMEDD-MC48LW2 EUDAMEDD-MC12LUZ EUDAMED
- Basic UDI-DI
- B-MC23LV9 EUDAMEDB-MC12LN98 EUDAMEDB-MC24MN9U EUDAMEDB-MC12SVF EUDAMEDB-MC24SVS EUDAMEDB-MC23MVB EUDAMEDB-MC12MV3 EUDAMEDB-MC57LNAV EUDAMEDB-MC35LVL EUDAMEDB-MC57LW4 EUDAMEDB-MC24MVE EUDAMEDB-MC12MN9B EUDAMEDB-MC25LVF EUDAMEDB-MC48LW2 EUDAMEDB-MC12LUZ EUDAMED
- EMDN Code
- A05010201 ELASTOMERIC SYSTEMS - VARIABLE 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 M4C 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-MC23LV9 | 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 (15)
- EUDAMED 37dfb2d5-2641-4ff6-a32c-e979282b4aca 61 fields · synced Oct 6, 2026
- EUDAMED a11cd42a-10f2-4288-be3e-b1d97e43e3ff 61 fields · synced May 11, 2026
- EUDAMED 78b43d83-630b-4f2a-96da-b5da4c456acc 61 fields · synced May 16, 2026
- EUDAMED fb943c0e-be3b-4482-b370-067ea49d56e2 61 fields · synced May 16, 2026
- EUDAMED db57699c-ed57-4310-ab4c-4e749f17d7ee 61 fields · synced May 16, 2026
- EUDAMED 5246a15e-ad1f-4784-ad1e-d8b7b3e8a4cc 61 fields · synced May 17, 2026
- EUDAMED 40b59fde-89f8-4ef0-9764-beb98c54fa98 61 fields · synced May 18, 2026
- EUDAMED a705d724-1e6f-4104-8a3d-6c8a1fdcbf1a 61 fields · synced May 18, 2026
- EUDAMED 8f9d793d-3934-4ef5-8ff7-c41664882f5f 61 fields · synced May 18, 2026
- EUDAMED 5599f925-d604-4c94-9a73-3cc24160ef20 61 fields · synced May 18, 2026
- EUDAMED d9182f18-dcc2-4cbc-9e6d-0fd7a3759395 61 fields · synced May 18, 2026
- EUDAMED df078bd8-7dba-4c1d-8666-7fa5cdc1027c 61 fields · synced May 18, 2026
- EUDAMED be899fa6-eb30-4ee4-b88d-b8d22ed382d2 61 fields · synced May 18, 2026
- EUDAMED 6d5eaa81-9ef2-4ad8-99ff-61331d560f77 61 fields · synced May 19, 2026
- EUDAMED af011106-f6b2-4104-8077-919853681914 61 fields · synced May 19, 2026