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Accufuser M16C
EUDAMEDClass IIb (EU MDR)
Ref MC0124M-NModel MC0124MRef MC1248SRef MC1248LRef MC0124LRef MC1248S-NRef MC1248M-NModel MC1248MRef MC1248XLRef MC0124SRef MC1248L-N
Identity
- Device Name
- Accufuser M16C EUDAMED
- Model / Reference
- MC0124M EUDAMEDMC0124M-N EUDAMEDMC1248S EUDAMEDMC1248L EUDAMEDMC0124L EUDAMEDMC1248S-N EUDAMEDMC1248M EUDAMEDMC1248M-N EUDAMEDMC1248XL EUDAMEDMC0124S EUDAMEDMC1248L-N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-MC0124MNZF EUDAMEDD-MC1248SL6 EUDAMEDD-MC1248LKQ EUDAMEDD-MC0124LJG EUDAMEDD-MC1248SN3W EUDAMEDD-MC1248MN3C EUDAMEDD-MC1248XL49 EUDAMEDD-MC0124MJJ EUDAMEDD-MC1248MKS EUDAMEDD-MC0124SJW EUDAMEDD-MC1248LN39 EUDAMED
- Basic UDI-DI
- B-MC0124MNZF EUDAMEDB-MC1248SL6 EUDAMEDB-MC1248LKQ EUDAMEDB-MC0124LJG EUDAMEDB-MC1248SN3W EUDAMEDB-MC1248MN3C EUDAMEDB-MC1248XL49 EUDAMEDB-MC0124MJJ EUDAMEDB-MC1248MKS EUDAMEDB-MC0124SJW EUDAMEDB-MC1248LN39 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 M16C 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-MC0124MNZF | 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 (11)
- EUDAMED 44e3f68a-be9e-4660-8c21-546fbd0bdf28 61 fields · synced Oct 6, 2026
- EUDAMED 2c9bf242-c65f-4b5d-83e1-7baa362aeaf5 61 fields · synced May 17, 2026
- EUDAMED 8e947c76-f0de-4d55-bc2e-3de051f5674d 61 fields · synced May 17, 2026
- EUDAMED b63adb3e-8332-4f89-bb7a-e64747d5c439 61 fields · synced May 18, 2026
- EUDAMED 3051ab9b-e6b4-4f20-965b-d885b3b9e78b 61 fields · synced May 18, 2026
- EUDAMED b0861f60-c8ef-4868-9206-421be1089a58 61 fields · synced May 18, 2026
- EUDAMED 08efa8e2-07f4-4672-99a7-ebc5f882b4f3 61 fields · synced May 18, 2026
- EUDAMED 89d66b19-b7ca-44a9-88cd-50c2c9bb2b57 61 fields · synced May 18, 2026
- EUDAMED d5c458b4-db79-4930-a2fd-061636e6132f 61 fields · synced May 18, 2026
- EUDAMED 4ed7180b-1f0c-4b3c-8c88-0bdeabc43e10 61 fields · synced May 18, 2026
- EUDAMED b6ca402f-8f5d-4522-ba3f-a9565bf56d38 61 fields · synced May 18, 2026