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Accufuser M8S
EUDAMEDClass IIb (EU MDR)
Ref MS2012SRef MS4248MRef MS2124LRef MS5012MRef MS3248L-NModel MS3248LRef MS5124LRef MS4124MRef MS2248MRef MS3124MRef MS2012MRef MS5248LRef MS3012SRef MS3248XLRef MS5248XL-NModel MS5248XLRef MS3124LRef MS4124XLRef MS2124XL
Identity
- Device Name
- Accufuser M8S EUDAMED
- Model / Reference
- MS2012S EUDAMEDMS4248M EUDAMEDMS2124L EUDAMEDMS5012M EUDAMEDMS3248L EUDAMEDMS3248L-N EUDAMEDMS5124L EUDAMEDMS4124M EUDAMEDMS2248M EUDAMEDMS3124M EUDAMEDMS2012M EUDAMEDMS5248L EUDAMEDMS3012S EUDAMEDMS3248XL EUDAMEDMS5248XL EUDAMEDMS5248XL-N EUDAMEDMS3124L EUDAMEDMS4124XL EUDAMEDMS2124XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-MS2012SRJ EUDAMEDD-MS4248MTB EUDAMEDD-MS2124LRN EUDAMEDD-MS5012MS7 EUDAMEDD-MS3248LNCK EUDAMEDD-MS5124LSP EUDAMEDD-MS4124MSE EUDAMEDD-MS2248MSM EUDAMEDD-MS3124MS3 EUDAMEDD-MS2012MR6 EUDAMEDD-MS5248LTL EUDAMEDD-MS3012SRV EUDAMEDD-MS3248XLDK EUDAMEDD-MS5248XLN4A EUDAMEDD-MS3124LRZ EUDAMEDD-MS4124XLCK EUDAMEDD-MS2124XLBR EUDAMED
- Basic UDI-DI
- B-MS2012SRJ EUDAMEDB-MS4248MTB EUDAMEDB-MS2124LRN EUDAMEDB-MS5012MS7 EUDAMEDB-MS3248LNCK EUDAMEDB-MS5124LSP EUDAMEDB-MS4124MSE EUDAMEDB-MS2248MSM EUDAMEDB-MS3124MS3 EUDAMEDB-MS2012MR6 EUDAMEDB-MS5248LTL EUDAMEDB-MS3012SRV EUDAMEDB-MS3248XLDK EUDAMEDB-MS5248XLN4A EUDAMEDB-MS3124LRZ EUDAMEDB-MS4124XLCK EUDAMEDB-MS2124XLBR 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 M8S 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-MS2012SRJ | 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 (17)
- EUDAMED 2c3399e8-6c3f-4c08-bc9b-fd6f4dc14bac 61 fields · synced Oct 6, 2026
- EUDAMED 30053e51-5cfa-4798-a37f-56088c6cec10 61 fields · synced May 17, 2026
- EUDAMED 564d059e-a3c7-4d94-91c8-fc2133fd60f5 61 fields · synced May 17, 2026
- EUDAMED 41273d04-5918-4bba-8a3f-bd7e72dc5a5b 61 fields · synced May 17, 2026
- EUDAMED 13ec772b-0be7-49e6-80d6-db180837c90a 61 fields · synced May 17, 2026
- EUDAMED bd176fc8-6ec8-4fb2-a546-83298263f3d1 61 fields · synced May 17, 2026
- EUDAMED c0995c5d-b173-4d30-8f0e-10184f0dc08c 61 fields · synced May 17, 2026
- EUDAMED 3df3e6a1-2a9e-4cc9-b0b7-0898d0d96eff 61 fields · synced May 17, 2026
- EUDAMED ce8be71b-fac2-4835-8b40-483a6cb8bd83 61 fields · synced May 17, 2026
- EUDAMED 64bc75b2-78ac-469c-88b1-67805b7ef26e 61 fields · synced May 18, 2026
- EUDAMED b029ed42-d67a-4562-8f82-afc339d77279 61 fields · synced May 18, 2026
- EUDAMED 8f3657fa-271d-4163-aaf6-aa1fd6b398cc 61 fields · synced May 18, 2026
- EUDAMED c5baba93-7143-4b2c-83e2-3228453736d3 61 fields · synced May 18, 2026
- EUDAMED 5b13729a-14d5-4c23-be46-cc8566192f73 61 fields · synced May 18, 2026
- EUDAMED c943f172-4fe5-4f9b-81b0-157bee47baff 61 fields · synced May 18, 2026
- EUDAMED 6c923cf2-1eb7-45a7-a369-37f94d538070 61 fields · synced May 18, 2026
- EUDAMED d88be892-4be5-40bf-b9f8-fd71c1d1ebb7 61 fields · synced May 19, 2026